{"paper_id":"50d2abae-354a-4a5c-84cd-f517590f4ac6","body_text":"Arch Clin Obs Gyn Res. (2024) Vol 3, Issue 1\nPage 1 of 24\n        Original ArticleArchives of Clinical Obstetrics \nand Gynecology Research \nCitation: Ahmed AIH. Feasibilty of a Double Blind Randomised Controlled Trial to Compare Post-operative Recovery following \nLaparoscopic Hysterectomy with Post-operative Recovery following Laparoscopic Sub-total Hysterectomy - The LaHoST Study. \nArch Clin Obs Gyn Res. 2024;3(1):1-24.\nFeasibilty of a Double Blind Randomised \nControlled Trial to Compare Post-operative \nRecovery following Laparoscopic Hysterectomy \nwith Post-operative Recovery following \nLaparoscopic Sub-total Hysterectomy - The \nLaHoST Study\nAbu Imad Hasib Ahmed1,2, Hany Wisa3, Jeremy Wright (ret)4\n1Medway Maritime Hospital, ME7 5NY Kent, UK \n2Canterbury Christ Church University, ME4 4UF, Kent UK \n3Associate Specialist Obstetrician and Gynaecologist, Medway Maritime Hospital ME7 5NY Kent UK\n4University of Surrey GU2 7XH, Guildford UK.\nCorrespondence\nAbu Imad Hasib Ahmed\nMedway NHS Foundation Trust, Gillingham, \nKent ME7 5NY, United Kingdom\n• Received Date: 25 Aug 2024\n• Accepted Date:  15 Sep 2024\n• Publication Date: 18 Sep 2024\nAbbreviations: BSO: Bilateral Salpingo-\noophorectomy; CES-D: Centre for \nEpidemiology Scale for Depression; \ne-PAQ: electronic Personal Assessment \nQuestionnaire; FSFI: Female Sexual Function \nIndex; HRT: Hormone Replacement therapy; \nIBS: Irritable Bowel Syndrome; LAVH: \nLaparoscopic Assisted Vaginal Hysterectomy; \nLH : Laparoscopic Hysterectomy; LSH: \nLaparoscopic Supracervical (Sub-total) \nHysterectomy; RCT: Randomised Controlled \nTrial; SAH: Supracervical (Sub-Total) \nAbdominal Hysterectomy; SF-36: Short \nForm 36; STAI: State Trait Anxiety Index;TAH: \nTotal Abdominal Hysterectomy; TLH: Total \nLaparoscopic Hysterectomy; USI: Urinary \nStress Incontinence; WHQ: Womens Health \nQuestionnaire \nCopyright\n© 2024 Authors.  This is an open- access \narticle distributed under the terms of \nthe Creative Commons Attribution 4.0 \nInternational license.\nAbstract\nObservational studies suggest faster recovery and quicker return to normal activities following \nlaparoscopic supracervical hysterectomy (LSH) compared with laparoscopic hysterectomy (LH) in \nwomen with benign uterine disease.  Data from the only randomised controlled trial (RCT) on the topic \ndoes not support this observation.\nWe have investigated the feasibility of a double blind RCT comparing post-operative recovery following \nLH with that following LSH. 70 women were invited to participate from a single gynaecological \nsurgeon’ s caseload 20 women were excluded. Web based randomisation was carried out at the time of \nstudy laparoscopy. Surgery was performed using a standardised technique.\nParticipants and the data handler were blinded to treatment allocation.  \nPrimary outcome was feasibility of recruitment. Secondary outcomes included validated post-operative \nrecovery and mood questionnaires at baseline, prior to discharge and at weekly intervals for 12 weeks.  \nValidated questionnaires regarding pelvic floor function and sexual function were assessed at baseline, \n6 weeks and 6 months. Recruitment and treatment of 50 women was completed within 18 months. Less \nthan 30% of eligible invitees were excluded and the commonest reason for exclusion was a strong \nopinion regarding conservation or removal of the cervix (8/70 = 11.4%). 96% of participants received \ntreatment according to randomisation. Data collection was complete at 6 weeks for 88%. Recovery \nscores were similar to pre-op at 3 weeks for LSH and at 4 weeks for LH.  Subjects had returned to normal \nactivity ‘all of the time’ by 6 weeks for LSH and by 8 weeks for LH. \nIn conclusion the definitive study appears feasible.  The observed advantage in short term recovery \nfollowing LSH compared to LH appears to be supported. If a difference in QoR score of 5 is clinically \nsignificant and power is set at 0.8 with α at 0.05 the definitive study will require 186 women in either \narm.\nBackground\nHistorical Perspective\nCharles Clay is credited with the first \nhysterectomy in the United Kingdom in 1843 \n[1]. The procedure was a subtotal hysterectomy \nperformed for an incorrect diagnosis without \nanaesthesia. A similar operation in another \npart of Manchester the same month was \nperformed by A.M. Heath [2]. In both \ninstances the women died from massive \nhaemorrhage within a few hours. It was not \nfor another 20 years that the operation was \nperformed for the correct diagnosis and the \nwoman survived.\nThe early operations to remove the womb \nwere all sub-total abdominal hysterectomies, \na technically simpler procedure avoiding \nopening of the vagina with perceived reduced \nrisks of infection and urinary tract injury. \nAround the turn of the last century Johannes \nPfannenstiel introduced the low transverse \nincision [3] with a reduction in wound \ndehiscence rates and shorter recovery. In \n1929 Richardson advocated total abdominal \nhysterectomy (TAH) in order to prevent cancer \nin the retained cervical stump [4].\nIn England and Wales approximately 36000 \nhysterectomies are performed per year and 58% \nof these are performed abdominally [5]. Over \n40% of the uteri removed are histologically \nnormal. Hysterectomy is also a treatment for \nmalignant disease of the uterus which is not \nthe subject of this study.\n\nPage 2 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nTotal versus Subtotal Hysterectomy Debate\nThe default towards total hysterectomy persisted until a \nScandanavian prospective study suggested that retention of \nthe cervix may be important in subsequent sexual function \n[6]. The findings were not confirmed by a number of authors \nincluding a subsequent study by the same group. Even prior \nto effective cervical screening the incidence of cervical stump \ncarcinoma was as low as 0.4% [7]. With the advent of cervical \ncancer screening programmes the incidence of cervical stump \ncancer has reduced further [8]. If the endocervical mucosa is \ncoagulated the incidence of stump carcinoma is as low as 0.11% \n[9]. It follows that in women at low risk for cervical carcinoma \nsupracervical hysterectomy is a realistic option.\nThe observed advantages of subtotal abdominal hysterectomy \n(SAH) compared to total abdominal hysterectomy (TAH) on \nsexual function [6,10,11] are unsubstantiated by a randomised \ntrial [12]. Outcomes using the EQ5D were significantly better \nin the SAH compared to the TAH arms in a more recent RCT \n(no significant difference at baseline compared to a difference \nat 1year of 0.15, p<0.05 [13]. There was improvement of health \nrelated quality of life in both the SAH and TAH groups but \nthe improvement was more pronounced in the SAH group \nin the Gorlero study. Similarly the previously observed \nbenefit of SAH on urinary function compared to TAH [14] \nwas actually reversed following an RCT [15]. The St George’s \nHospital group in South London attempted to address the \ncontroversy. Two hundred and seventy nine women who were \nawaiting abdominal hysterectomy were randomised to SAH \nor TAH. Quality of life was assessed with short form 36 (SF-\n36) and general health questionnaire 28 (GHQ-28) at 6 and 12 \nmonths. No significant differences were found [16,17]. Later \nquestionnaires with a response from 64% of the original cohort \nshowed no significant difference [18].  Analysis of secondary \noutcomes showed statistically significant more multiple \norgasms in the SAH arm and reduced coital frequency in the \nTAH arm. A non-significant higher rate of dyspareunia was \nnoted in the TAH arm. There were more vault haematomas in \nthe SAH group and, somewhat surprisingly, an increased rate of \ncervical prolapse. Others have previously reported that pelvic \norgan prolapse post hysterectomy is rare and does not appear \nto be related to the method of hysterectomy [19]. Theoretically \ncervical prolapse following SAH should be uncommon as \nthe uterosacral cardinal complex supports of the cervix are \npreserved. This raises the question as to whether some of the \nparticipants in the St Georges study may have had pre-exisitng \nuterine prolapse and may have been more suitable for vaginal \nhysterectomy perhaps with a vault suspension procedure.\nShort term recovery following TAH and SAH was the \nsubject of a recent Swedish RCT [20,21]. Of the 200 recruits \n178 completed the study. Participants were assessed daily \nusing visual analogue scores for wellbeing, and 4 validated \nquestionnaires from 7 days before the hysterectomy until 35 \ndays after. No significant differences were noted between the \ngroups at 6 weeks, 6 months and 12 months.\nThe comparison of TAH and SAH has been the subject of a \nnumber of systematic reviews. A Cochrane review reported \nin 2006 included only 3 randomised controlled trials with \n733 participants [15,16,22]. The Author’s concluded that \nthe perception of better sexual, urinary and bowel function \nfollowing SAH when compared to TAH remained unproven \n[23]. Scandinavian countries have led the way in terms of \npreference for SAH over TAH with 56% preference for the \nformer in Sweden [24] and 22% preference for SAH in Denmark \n[25]. Helga Gimbel performed a meta-analysis using Cochrane \nmethodology on data from 4 RCTs, the 3 reported in the earlier \nCochrane review plus a small RCT, [26] and 11 observational \nstudies [27]. Counter-intuitively the meta-analyses showed \nan advantage in TAH over SAH with regards to urinary \nincontinence and prolapse. SAH was shown to be a somewhat \nfaster operation with less operative blood loss but there were \nmore complications related to cervical stump problems in \nkeeping with the Lethaby review [23]. Most importantly, \nno difference was noted in sexual function or psychiatric \nsymptoms between the 2 groups. The better sexual function \nargument had been the main driver for the drift towards SAH \nrather than TAH in the Scandinavian countries (Finland, \nNorway, Sweden and Denmark).The Cochrane review has \nrecently been updated [28] and now includes 9 RCTs with 1593 \nparticipants but not all of the participants were included for \nthe analysis of all parameters. The analysis of the additional \ndata supported the findings of the previous review of 2006. \nOnce again the perceived better outcomes in terms of sexual, \nurinary and bowel function in women undergoing SAH \ncompared to those undergoing TAH were unsubstantiated. \nThe small difference with regards to shorter operating times of \n11 minutes on average, and less blood loss of 57mls on average \nin SAH compared with TAH, are not clinically relevant. The \nincidence of post-operative febrile illness was higher in TAH \ncompared with SAH which is clinically important but should \neasily be amenable to correction with appropriate antibiotic \ntherapy. The incidence of post-operative vaginal bleeding for \nup to two years was, on average, 16 times more likely following \nSAH compared to TAH.  In summary extensive examination of \ndata with regards to the abdominal approach to hysterectomy \nhas failed to show a clinically important advantage of cervical \nconservation. The most recent Cochrane review included 2 \nstudies using the laparoscopic route to hysterectomy [29,30] \nbut the studies were underpowered to detect some differences. \nThis leads us on to a detailed discussion of laparoscopic \nhysterectomy.\nEnter the Laparoscope\nSince the 1960s the laparoscope has formed a central part of the \narmamentarium available to the gynaecologist. With improved \ninstrumentation therapeutic techniques have emerged using \nsmall incisions associated with less post-operative pain and \nfaster recovery in the ‘era of keyhole surgery’. Gynaecologists \nled the way with both laparoscopic appendicectomy [31] and \nlaparoscopic cholecystectomy [32].\nThe first total laparoscopic hysterectomy (TLH) was performed \nby Harry Reich in Pennsylvania in 1988 [33]. Despite this early \nstart uptake of the laparoscopic approach to hysterectomy \nhas been relatively slow and the majority of hysterectomies \nworldwide are still performed abdominally [34]. Since the \nfirst reported vaginal hysterectomy by Langenbekke in 1813 \nthe relative merits of vaginal versus abdominal hysterectomy \nhave been debated [2]. In ancient writings the first vaginal \nhysterectomy may have been as early as 120 AD by Soranus \nof Ephesus [35] and perhaps represents the first example of \nNatural Orifice Transluminal Surgery. \nLaparoscopic hysterectomy (LH) was included in the debate \nrelatively recently with Garry’s seminal ‘eVALuate study’ \n[36] comprising of 2 randomised parallel comparisons of \nlaparoscopic hysterectomy with vaginal and abdominal routes. \nThe design of the study included a 2:1 randomisation in both \n\nPage 3 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\narms in favour of the laparoscopic route. Indeed the Author’s \nstated in the introduction ‘there was urgent need to define the \nrole of the laparoscopic approach to hysterectomy before this \nwas introduced extensively into clinical practice’. Whether \nparticipants were recruited onto the abdominal or vaginal arm \nof the study was left to the clinical discretion of the investigator. \nPrimary outcomes were predefined major complications, both \nimmediate and short term. Secondary outcomes included \npredefined minor complications, pain scores with analgesic \nrequirement and data from 3 validated questionnaires. The \nstudy showed a clear benefit in the vaginal hysterectomy \ngroup but the laparoscopic arms of both the vaginal and \nabdominal trials were associated with longer operating times \nand significantly higher complication rates, especially with \nregards to urinary tract injuries. The crucial question is why \nwere there so many complications in the laparoscopic arms \nof both studies? Laparoscopic hysterectomy was a very new \nprocedure having been reported in the literature for the first \ntime in 1989. The new technique was being compared to \nabdominal hysterectomy which was at least 150 years old and \nvaginal hysterectomy which had been practised for even longer. \nThe study was recruiting when laparoscopic hysterectomy \nwas just beginning to be introduced by enthusiasts. The \nminimum experience required for a surgeon to recruit to \nthis study was 25 laparoscopic hysterectomies. The surgeon \nwith the most experience with the new technique need not \nhave been the primary surgeon and no standard technique \nwas specified. In a very simple observational study based on \ndata from the Finnish Hospital Registry, outcomes following \nlaparoscopic hysterectomies performed between 1992 and \n1999 were compared with outcomes following laparoscopic \nhysterectomies performed between 2000 and 2005 [37]. \nApproximately 14000 women were in each cohort and the \noverall incidence of major complications reduced from 1.8% in \nthe earlier cohort to 1% in the later cohort. Specifically urinary \ntract injuries reduced by half (1.4 to 0.7%) and ureteric injuries \nreduced to one third (0.9% to 0.3%) when the earlier cohort \nwas compared with the later cohort. This is very compelling \nevidence that the learning curve for laparoscopic hysterectomy \nis much longer than the 25 cases required to be eligible to \nrecruit to the eVALuate study. The lack of standardisation \nof technique is particularly relevant as 43 gynaecological \nsurgeons were involved from 30 different centres. Almost 25% \nof all major complications in the laparoscopic arms of the \nstudy occurred when suturing was the method of securing \nhaemostasis of the ovarian pedicle. Almost 75% of all major \ncomplications in the laparoscopic arms of the study occurred \nwhen suturing was the method of securing haemostasis of \nthe uterine pedicle. Laparoscopic suturing was being used by \nonly 2 of the 43 participating surgeons, was not the recognised \ntechnique and significantly skewed the results. The more \ncommonly used ‘safer’ techniques of the time were bipolar \ndiathermy and linear staplers. On closer analysis almost all \nof the ureteric injuries occurred in the centre that employed \nlaparoscopic suturing. Unintended conversion to laparotomy \nwas considered a major complication and occurred in 32 \nintended laparoscopic procedures. Appropriate conversion to \nlaparotomy for the safety of the patient should be considered \ngood surgical technique and not a major complication. Another \nsignificant challenge to the study was under recruitment. The \noriginal power calculations required 1800 patients in total split \ninto 1048 in the abdominal arm and 752 in the vaginal arm. The \nstudy recruited 1380 in total and was underpowered to find any \ndifference in the vaginal arm. The eVALuate study confirmed \nthe advantages of avoiding laparotomy for hysterectomy seen \nin previous smaller studies but concluded that this was at a \ncost of higher major complications. In the same issue of the \nBMJ Jacques Donnez et al [36] reported their observational \nsingle centre data with much lower major complication rates \nof 0.6% in laparoscopic supracervical (sub-total) hysterectomy \n(LSH) and 2% in TLH. Professor Donnez’s major criticism of \nthe high complication rates in the eVALuate study was the lack \nof experience of many of the surgeons involved and the use of \npoor technique. The issue was the subject of a Cochrane review \n[38] incuding 27 randomised controlled trials (RCT)s and 3643 \nparticipants. The largest number of patients were from the \neVALuate study and the conclusions, not surprisingly, were in \nline with those of the eVALuate study. The Author’s concluded \nthat where possible vaginal hysterectomy is the method of \nchoice but where vaginal hysterectomy is not deemed possible \nconsideration should be given to LH as long as the higher risk of \nmajor complications are acceptable. The eVALuate study may, \nin part, explain the slow uptake of laparoscopic hysterectomy \nin gynaecology when our colleagues in gastrointestinal and \nurologic surgery were moving on at pace. The Donnez group \nhave updated their single centre data [39] to include 4505 \npatients between 1990 and 2006 with 0.19% ureteric injury rate \nin LSH and 0.32% in laparoscopic total hysterectomy (LTH) \na conglomerate of laparoscopic assisted vaginal hysterectomy \n(LAVH), LH and TLH. The Cochrane review has also been \nupdated [40] to include 34 studies with 4495 women. The \nadditional data has not changed the Author’s conclusions but \nthe increased power allowed some comparison of LAVH and \nTLH. This leads us on to a discussion of the debate around LSH \nand LH.\nTotal versus Subtotal Laparoscopic Hysterectomy Debate\nThe late pioneering German gynaecological surgeon, \nKurt Semm, published a ‘classic intrafascial supracervical \nhysterectomy’ using ‘pelviscopy’ in 1989 [41]. Semm’s \ntechnique involved a novel ‘calibrated uterine resection tool’ \nto core out the cervix with removal of the uterus via a ‘serrated \nedged macro-morcellator’.\nThis technique in a variety of forms has been reported in \nobservational studies as leading to faster recovery and faster \nreturn to normal activities when compared to laparoscopic \nhysterectomy when both the body of the uterus and cervix are \nremoved [42-44]. If this advantage is real the implications to \nwomen undergoing this surgery may be important, both in \nterms of patient morbidity but perhaps even more relevant in \nthe current financial climate: with respect to faster return to \nwork and contribution to the wider society. In hospital stay \nwas not significantly different whether subtotal hysterectomy \nwas performed abdominally or laparoscopically in one \nScandinavian study which employed a form of the enhanced \nrecovery programme to the abdominal arm [45]. However, \nOscarrson and colleagues did confirm greater disability days \nfollowing discharge from hospital in the SAH group versus the \nLSH group. Observational [46] and randomised studies [47] \nfrom Oslo University hospital confirm that LSH is consistently \npossible within the outpatient setting. However, the RCT \nfound a deleterious effect on quality of life measures in the \npatients operated on as day cases. Others routinely discharge \nLSH patients home the same day [48-50] with no apparent \nincrease in readmission rates.\nTheoretically in the LSH technique less extensive separation \n\nPage 4 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nof the bladder from the cervix and removing the uterus at \nthe level of the internal os should, intuitively, be associated \nwith fewer bladder and ureteric injuries than in LTH.  More \nrecent observational comparisons of the two techniques have \nproduced conflicting results. Two retrospective studies have \nshown fewer baldder injuries in LSH compared with LTH \n[51,52] but in a Canadian smaller retrospective study bladder \ninjury rates were comparable between the two groups [53]. \nNone of the studies showed a difference in ureteric injury rates \nbut much larger numbers would be required to show a real \ndifference. A prospective comparison has shown no difference \nin operating time between LSH and LTH [54] in keeping with \nthe largest retrospective review [51] but Cipullo reported longer \noperating times with LTH compared to LSH [52]. An earlier \nstudy showed longer operating times with LAVH compared to \nLSH [55]. In the largest retrospective study the hospital stay \nwas on average 5 hours longer for LTH compared to LSH [51]. \nAlthough the difference was statistically significant this does \nnot constitute a clinically important difference. Of much more \nrelevance is days taken to return to normal activities which \nwas not examined in the study. In a small prospective study \nno difference in quality of sexual life was found between the 2 \ntechniques [56]. In a smaller RCT sexual function improved in \nboth LTH and LSH groups compared to non-hysterectomised \ncontrols but there was no difference according to the type of \nhysterectomy performed [57]. These findings were in keeping \nwith an earlier RCT and parallel observational study [58]. In \na larger more recent RCT a definite advantage was observed \nfollowing SAH with regards to sexual pleasure and orgasm \nfrequency but the authors encourage caution when interpreting \nthe results [59]. The inclusion criteria were narrower than \nmany other studies and enrolled only premenopausal women \nin whom the ovaries were to be conserved. There is no clear \nconsensus regarding laparoscopcic conservation of the cervix \nat the time of hysterectomy and subsequent sexual function.\nThe advantage of LSH versus LH seen in some observational \nstudies has not been confirmed in the only published \nrandomised comparison of LSH with TLH which examined \nshort term outcomes including recovery [30]. The study had \na number of limitations. The study screened 529 women but \nonly 154 premenopausal women with abnormal uterine \nbleeding or symptomatic fibroids were assessed as eligible, \nof which 141 agreed to randomisation. The Authors did not \npresent the reasons for exclusion of 388 women, over 73% of \nthose screened, which may represent selection bias. 6 patients \nin each group did not have the intended intervention due to \ntechnical/clinical reasons (8.4-8.6%) and it is not clear whether \nthe outcomes were analysed according to intention to treat. \nWith regards to post-operative recovery, the Authors did not \nstipulate the tool used to assess recovery and whether this is \nvalidated. Furthermore the participants were assessed at 3 \nmonthly intervals from operation for 24 months. Case series \nsuggest recovery from LSH occurs much earlier with return \nto normal quoted from within 3-21 days [60,61]. It follows \nthat in order to detect a difference in recovery between the 2 \ntreatment groups frequent assessments are necessary during \nthe first 3 months following surgery. More minimally invasive \ntechniques for treatment of menstrual disorders have been the \nsubject of randomised comparisons against LSH. Although \nendometrial resection and thermal balloon ablation are \neffective treatments for menometrorrhagia, overall satisfaction \nfollowing LSH is significantly better [61,62].  \nThe question of whether SAH has advantages over TAH \nappears to have been answered and no advantage has been \nconfirmed. However, the same question with regards to the \nlaparoscopic route is far from answered. We aim to address \nthis enormous gap in the literature by conducting a feasibility \nstudy of an RCT to compare recovery, pelvic floor and sexual \nfunction following LSH with LH. To our knowledge this \nquestion has not been adequately addressed. \nFeasibility Study Rationale\nThe current study is reported according to the published \nConsolidated Standards for Reporting Trials [63]. \nOne definition of a feasibility or pilot study includes \npreliminary test or trial run of an investigation designed to \ntest the feasibility of methods and procedures for later use on a \nlarge scale or to search for possible effects and associations that \nmay be worth following up in a subsequent larger study’ [64]. \nThe British Medical Research Council explicitly recommends \nthe use of feasibility studies prior to Phase III trials [65]. Phase \n3 studies are large, double-blind, randomized, controlled trials \non large patient groups designed as the definitive assessment \nof a new therapy's efficacy, especially in comparison \nwith currently available alternatives ( www.geovax.com/\ntechnologyandproducts/glossary.php). The main goal of a \nfeasibility study is to avoid embarking on a large scale study \nwhich may fail to recruit or fail to complete, thereby wasting \nresources in terms of time and effort.\nAims and Objectives\nIn keeping with these recommendations we set out to assess \nthe feasibility of conducting a randomised, double blinded \ncomparison of post-operative recovery following laparoscopic \nhysterectomy (LH) with that following laparoscopic \nsupracervical hysterectomy (LSH). The paucity of grade 1 \nevidence on the topic was established following a systematic \nreview of the literature as described in Appendix 1and is \ndetailed in the background section.\nThe primary aims of the feasibility study are in keeping \nwith examination of process, resources, management and \nscientific factors which have previously been defined as \nthe cardinal aspects of pilot studies [66]. The process was \ninvestigated in terms of recruitment rate, refusal rates, \ncompletion rates and non-compliance with protocol rates. \nResources and management were investigated in terms of time \nto obtain informed consent, time to administer and input \nquestionnaires, hardware, software requirements and time \nfor statistical analysis. Scientific factors which were examined \nincluded immediate/short term complications, quality of \nrecovery, depression scores, pelvic floor and sexual function \nusing validated questionnaires. The primary aim of the \ndefinitive study is to detect a clinically important difference \nin quality of recovery between women undergoing the 2 types \nof laparoscopic hysterectomy under study. The corresponding \nnull hypothesis is that there is no difference in recovery and \nshort term outcomes in women undergoing laparoscopic \nhysterectomy (LH) when compared with women undergoing \nlaparoscopic supracervical hysterectomy (LSH).\nTo our knowledge there has been no published RCT comparing \nLSH with LH. The approach of choice for extirpation of the \nuterus for benign indications is vaginal hysterectomy (VH). \nWhen VH is not practicable LH should be offered but there is \npaucity of evidence with regards to which type of laparoscopic \nhysterectomy should be offered. The feasibility study outlined \nis designed to assess whether it is realistic and practicable to \nrecruit to an RCT aimed at addressing this enormous gap in \n\nPage 5 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nthe literature.\nThe primary outcomes of the definitive RCT are post-\noperative recovery, post-operative mood states, intermediate \nterm urinary, bowel and sexual functioning. The feasibility \nstudy will allow detailed assessment of recruitment to the \nproposed RCT in a single centre (Author’s main hospital of \npractice) with a single primary surgeon (Author).\nThe quantitative results of the feasibility study will be used \nto inform power calculations to estimate numbers required \nfor the definitive study. Secondary aims of the definitive study \nwould include long term comparisons of pelvic floor and \nsexual function between women undergoing LH and LSH. \nAlthough these outcomes have been extensively investigated \nwith regards to abdominal hysterectomy, no comparisons exist \nfor the laparoscopic approach. The feasibility study was granted \napproval from the National Research Ethics Committee and \nthe Local Research Ethics committee (Appendix X).\nIt is important to predefine the criteria for success of a \nfeasibility study at the outset [67]. The feasibility study was \nset up to recruit 50 participants over 12 months and complete \nall surgery within 6 months of recruitment. All outcome data \nwould be collected within a further 6 months. The number of \nparticipants was arbitrarily based on the principal investigators \nclinical caseload (approximately 75 eligible women per year). \nPredefined criteria for determining success of the feasibility \nstudy are listed below. \nRecruitment and data collection should be completed within \n2 years of study commencement.\nMore than 70% of eligible women approached to take part \nshould agree to randomisation.\nA minimum of 95% of participants should have treatment \naccording to randomisation.\nAll data should be complete at baseline (QoR-40, CES-D, \ne-PAQ and FSFI).\nThe randomisation procedure used should reliably rule out \nselection bias and be simple to administer.\nThe study protocol should ensure reliable blinding of \ntreatment allocation from the patient and the data handler.\nA minimum of 85% should have complete recovery data at 6 \nweeks.\nA minimum of 75% should have complete recovery data at 12 \nweeks.\nA minimum of 85% should have complete e-PAQ and FSFI \ndata at 6 weeks. \nA minimum of 70% should have complete e-PAQ and FSFI \ndata at 6 months.\nThe process of completing the questionnaires should be \nsimple to understand and be completed within 10 minutes for \nthe short questionnaires (QoR-40 and CES-D) and within 30 \nminutes for the longer questionnaires (e-PAQ and FSFI).\nMaterials and Methods\nSetting\nThe setting was a district general hospital in the Southeast \nof England, Medway Foundation Hospital, an associate \nUniversity Hospital to the University of London.\nInclusion Exclusion Criteria\nThe recruits were premenopausal women who had completed \ntheir families and had a benign indication for hysterectomy. \nWomen were excluded if the uterine size was estimated as \ngreater than that of a 16 week pregnancy at the time of surgery \nor if there was greater than first degree uterine prolapse at \nexamination under anaesthetic. Recruits were required to be \nup to date with cervical cytology screening and on a routine \nrecall schedule. If a smear was due this was taken at the \ninitial invitation to the study. The recruits were from a single \nclinician’s caseload and the surgery was completed by the \nnamed clinician. \nInclusion criteria are summarised below.\n• Benign indication for hysterectomy\n• Uterine size < 16/40\n• Normal cytology & on routine screening schedule\n• No more than 1st degree prolapse\n• Premenopausal\n• Family complete\nExclusion criteria are summarized as\n• Postmenopausal women\n• Undiagnosed abnormal vaginal bleeding\n• History of high grade cervical intraepithelial neoplasia\n• Uterovaginal prolapse > stage I [68]\n• Previous gynaecological malignancy\n• Previous extensive pelvic surgery\n• Current use of antidepressant/antipsychotic treatment\n• Inability to read or write fluently in English.\nPotential recruits were invited to participate in the clinic setting \nat the time of discussion regarding treatment by laparoscopic \nhysterectomy. Hysterectomy as a treatment was discussed \nin general as per the principal investigators normal clinical \npractice. The two different types of laparoscopic hysterectomy \non offer (Stage 4 and stage 6 Garry and Reich classification)[69] \nwere discussed in detail and written information was supplied \nto support the discussion (Appendix II). Potential recruits were \nformally invited to take part by letter (Appendix IIIa) and were \ngiven specific information about the study (Appendix IIIb and \nIV). Potential recruits were seen again at an interval of 2 to \n4 weeks for completion of consent. Those women agreeing to \ntake part were formally invited onto the study at the time of \nconsent. The informed consent process was in keeping with \ngood clinical practice and it was made absolutely clear that \nthe participants were at liberty to withdraw consent from the \nstudy at any time.\nStandardised Surgical Technique\nA standardised surgical technique was used for both arms of \nthe study. There are numerous descriptions for LSH and LH \nin the literature. The procedures were carried out according \nto the usual practise of the principal investigator who was \nthe primary surgeon for all 50 cases. A large part of both \nprocedures are the same and will be described first. General \nanaesthesia is induced and maintained by a single anaesthetist. \nA size 12 Foley catheter is inserted into the bladder and a \nPelosiTM (CooperSurgical, Connecticut USA) manipulator is \nused to cannulate the endometrial cavity.\nA 5mm primary bladeless, dilating tip trocar (Excel™, Ethicon, \nCinncinati, USA) is inserted into the umbilicus under direct \nvision. Once intraperitoneal placement is confirmed a carbon \ndioxide pneumoperitoneum is established at a pressure of \n15mmHg. The patient is placed in 30° Trendelenberg and 3 \naccessory ports are inserted under direct vision. The position \n\nPage 6 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nof the ports are lateral at the level of the umbilicus on either \nside and the third, 2 fingers breadth above the symphysis \npubis. The two lateral accessory ports are 5 mm in diameter \nand the suprapubic port is 12mm in diameter. Smart bipolar \ntissue fusion via a single use 5mm diameter blunt tip forcep \nwith tissue sensing (LigasureTM Covidien, Mansfield \nMassachusetts, USA) is used to coagulate the proximal portion \nof the left Fallopian tube and utero-ovarian ligament, if the \novary is to be conserved, or the left infundibulopelvic ligament \nif removal of the ovary is desired, after identification of the \nposition of the ureter at the pelvic brim. Coagulation and \ndissection are continued through the round ligament to gain \naccess to the space between the 2 leaves of the broad ligament. \nThe uterovesical fold of peritoneum is dissected with scissors \nand monopolar diathermy at 30W cutting. The bladder flap \nis reflected caudad. A posterior peritoneal flap is similarly \ndissected and reflected to mobilise the ureters caudad. The \nascending branch(es) of the left uterine arteries are coagulated \nbut not transected with the tissue sensing bipolar forceps. The \nsteps are repeated on the right side of the pelvis after delineation \nof the pelvic course of the right ureter. The remainder of the \nprocedure differs according to treatment allocation. \nFor LH the main trunk of the uterine artery is coagulated \nand transected superomedially to the course of the ureter. The \nuterosacral ligaments are coagulated close to the arch of the \nuterosacrals. The remainder of the procedure is carried out via \nthe vagina after removal of the uterine manipulator. Forty mls \nof 1:200 000 adrenaline in normal saline solution is infiltrated \ninto the subcuticular space around the cervix taking care to \navoid intravascular injection. The cervix is circumscised with \na monopolar angled needle using blended diathermy of 100W \ncutting and 60W coagulation. The supra-vaginal septum is \ndivided to allow cranial reflection of the bladder. The Pouch \nof Douglas is entered with a single cut into the peritoneum \nunderlying the vaginal skin in the posterior vaginal fornix. \nThe uterosacral ligaments are clamped with curved Zeppelin \nclamps, cut, transfixed and ligated with 1 Vicryl® (Ethicon \ndivision of Johnson & Johnson, New Jersey, USA) prior \nto removal of the uterus and cervix. The vaginal skin and \nperitoneum are sutured en-masse with locking 0 Vicryl® and \nsuspended to the uterosacral ligaments.\nIn the case of LSH the ascending branches of the uterine \narteries are coagulated but not transected at just below the \njunction of the uterine corpus and cervix. The Pelosi uterine \nmanipulator is removed. A 100W monopolar diathermy \nloop (Lap Loop™, Roberts Surgical, Worcester, UK) is used to \namputate the body of the uterus from the cervix. The uterus is \nmorcellated and removed piecemeal with a 15mm disposable \nmorcellator (Morcellex Gynecare division of Johnson & \nJohnson, New Jersey, USA) which is inserted suprapubically \nwith a dilating tip blunt trocar. The endocervical canal and \ncervical stump are coagulated with bipolar diathermy. \nThe remainder of the procedure is the same for both techniques. \nHaemostasis is confirmed laparoscopically. A 4.7mm (14 gauge) \nRedivacTM drain is left in the pelvis through the right lateral \nport, secured with a silk suture and clamped for 30 minutes. \n30mls 2.5% chirocaine is instilled intraperitoneally. The \naccessory ports are removed under direct vision. The 12-15mm \nsuprapubic port site is closed with 1 Vicryl® on Endoclose® \n(Tyco, Hampshire UK).The pneumoperitoneum is deflated and \nthe laparoscope and primary trocar are removed under direct \nvision. The skin is closed with subcuticular 3-0 Vicryl Rapide® \n(Ethicon). 10mls 2.5% chirocaine is injected subcuticularly at \nthe port sites. The Redivac drain is removed when there is less \nthan 100mls drained in 6 hours after mobilisation out of bed. \nAnalgaesia is commenced per-operatively with intravenous \ndiclofenac 75 mg and paracetamol 1g together with 8 mg \ndexamethasone and 4mg ondansetron as antiemetic.\nPatients are transferred to the ward after recovery from \nanaesthesia. Hourly vital signs are maintained until stable and \nthen reduced to 4 hourly observations. The catheter is removed \nonce the patient is able to mobilise out of bed. The majority \nof patients are discharged within 1-2 days of admission with \nsimple analgaesia.\nRandomisation\nRandomisation was conducted at the time of laparoscopy \nusing a web based computer generated randomisation service \n(www.sealedenvelope.com/freerandomiser/v1).The reason \nfor randomisation after laparoscopy was so that only recruits \nin whom both techniques were deemed practicable were \nrandomised.\nOutcomes\nParticipants were asked to complete a number of validated \nquestionnaires prior to randomisation and then again prior to \ndischarge after surgery. Two short questionnaires were used, \nthe Quality of Recovery 40 (QoR-40 Appendix VI) [70] and the \nCenter for Epidemiologic Studies Depression Scale (CES-D, \nAppendix VII) [71]. In a systematic review of ‘Recovery \nSpecific Quality of Life Instruments’ [72] the QoR-40 was the \nbest validated tool with regards to short term post-operative \nrecovery. \nOperative findings were completed by the surgeon \nimmediately post procedure using a proforma (Appendix V). \nThe participants were requested to fill in the pair of short \nquestionnaires preoperatively, at discharge and at weekly \nintervals from the first post-operative week up to and including \nthe 12th post-operative week (fourteen pairs of questionnaires \nin total). A fifteenth pair of questionnaires were requested at \nthe sign off visit at 6 months. The QoR-40 poses 40 questions \nto the recipient, each of which are scored from a minimum \nof 1 to a maximum of 5. The global QoR-40 score may vary \nbetween 40 (worst possible recovery) and 200 (best possible \nrecovery) and the Author of the questionnaire has previously \nshown that a difference in scores of 5 is clinically important \n[70]. The CES-D includes 20 questions scored from 0 to 3 with \nminimum total score of 0 and a maximum possible score of \n60. A score of over 16 signifies depression. The majority of the \nshort questionnaires were completed electronically via secure \ne-mail (44 patients). The remainder were collected in hard \ncopy via stamped, self-addressed envelopes (6 patients).\nA further 2 validated questionnaires were used, a paper \nversion of the electronic Personal Assessment Questionnaire \nversion 10 (e-PAQ [73] Appendix VIII) and the Female Sexual \nFunction Index (FSFI [74] Appendix IX). The pair of long \nquestionnaires were given to the participants in paper format \nto fill out prior to admission, at 6 weeks and at 6 months.\nThe e-PAQ is available in electronic format but in view of the \ncost (£6000 p.a. recently reduced to £2000 p.a.) a paper format \nwas used. This questionnaire has questions divided into 4 \ndomains. Namely these are urinary, bowel, vaginal and sexual. \nThe domains are subdivided into 5 sub-domains in the case \nof urinary, bowel, and sexual domains and 4 sub-domains \nin the case of the vaginal domain. The score from each sub-\n\nPage 7 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\ndomain is multiplied by a factor to give a score out of a possible \nmaximum score of 100 (worst possible score) and a minimum \nscore of 0 (perfect score). The scores for each sub-domain \nare amenable to numerical comparison longitudinally i.e. at \nbaseline, 6 weeks and 6 months and between treatment groups. \nThe FSFI questionnaire consists of 19 questions which can \nscore between 1-5 (questions 1 & 2 desire domain) and between \n0-5 for the remaining questions (3-6 arousal domain, 7-10 \nlubrication domain, 11-13 orgasm domain, 14-16 satisfaction \ndomain and 17-19 pain domain). The scores for each domain \nare multiplied by a factor to give a maximum possible score of \n6. The total score for the questionnaire may vary from 2 (worst \npossible sexual function) to 36 (best possible sexual function). \nScores are amenable to intra-individual numerical comparison \nlongitudinally and between treatment groups. \nThe questionnaire data was inputted onto an Excel spread \nsheet and imported onto SPSS version 19 (SPSS Inc. Chicago, \nIllinois) for statistical analysis. The inputting of the data was \nundertaken without prior knowledge of treatment group \nallocation.\nResults\nRecruitment and surgery was completed in 18 months \nand data collection was concluded within 2 years of study \ncommencement (see chart 1 recruitment time line). \nRecruitment was slower than anticipated, particularly at the \noutset (50% longer to reach 50 recruits) but the predefined \noverall time to complete data collection was not exceeded so \nthis part of the study was deemed feasible. In the first 5 months \nonly 6 patients were recruited. If the intial slow months are \nexcluded the average recruitment rate was 4 participants per \nmonth with peak recruitment of 8 in month.\n50 participants were randomised from a potential 70 recruits. \nReasons for exclusion are summarised in table 1.\nThe commonest single reason for exclusion was a strong \nopinion regarding cervical conservation. Two women did not \nwant the cervix removed and 6 could not contemplate having \nthe cervix conserved (40% of all exclusions and 11.5% of total \ninvitees). Technically these were the only eligible women who \nwent on to have hysterectomy that refused randomisation. This \nis a refusal rate of 8/58 (13.8%). In 5 patients the symptoms had \nresolved and a further 2 changed their mind regarding major \nsurgery. One patient was excluded on the basis of abnormal \ncervical screening cytology taken at the invitation clinic visit. \nOne patient became pregnant whilst awaiting surgery as part \nof the study; she returned for surgery after the baby had been \ndelivered but was out of time with regards to the feasibility \nstudy. Three patients were excluded under anaesthetic. In one \ncase the cervix was inaccessible secondary to cervical fibroids, \nin another case a vaginal hysterectomy was performed; in \nthe third case the patient was found to have a frozen pelvis \nand hysterectomy was deferred until she had received formal \nbowel preparation. A fourth patient was excluded at the time of \nlaparoscopy because of an inadvertent injury to the transverse \ncolon at the time of insertion of the primary trocar. She \nhad previously had a laparoscopic cholecystectomy and the \ntransverse colon was adherent under the umbilicus. The injury \nwas immediately recognised and sutured without spillage of \nbowel content. She made an uneventful recovery and went \nhome on the second post-operative day. She subsequently re-\nenrolled on the study at an interval of 3 months. On the second \nReason for exclusion Number % total pa -\ntients (n=70)\nSymptoms resolved 5 7.1%\nDeclined conservation of cervix 6 8.6%\nDeclined removal of cervix 2 2.9%\nChanged mind and declined major \nsurgery 2 2.9%\nCervix inaccessible 1 1.4%\nSevere dyskaryosis at baseline cytol -\nogy 1 1.4%\nSuitable for vaginal hysterectomy 1 1.4%\nPregnant 1 1.4%\nFrozen Pelvis at index laparoscopy 1 1.4%\nIncluded 50 71.4%\nTotal 70 100.0%\nChart 1. Recruitment Time line\nTable 1. Reasons for Exclusion\nRandomised 50 \nAllocated LSH  \n25 \nAllocated LH  \n25 \nInvited 70 \nCompleted LSH \n25 \nOvaries Conserved \n10 \nCompleted 6w FU \nCompleted LH \n23 \nCompleted LSH \n2 \nOvaries Conserved \nExcluded 20 \nChart 2. Participant Flow\n\nPage 8 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\noccasion a Palmer’s point entry was used which facilitated \navoidance of her midline adhesions. She was randomised to \nLH but during the course of the procedure it became clear \nthat LSH was a safer option. After the initial protocol violation \ndata collection was completed uneventfully. Patient flow is \nsummarised in chart 2.\nAll surgery was performed by one surgeon (principal \ninvestigator). The participant was unaware of which procedure \nhad been undertaken and this was revealed after 1 year from \nthe operation so that participants could continue on the \ncervical screening programme if necessary. Data was put onto \nan Excel data base without prior knowledge of treatment status \nby the data handler.\nThe distribution of the quantitative data obtained from all \nthe questionnaires was tested using Komolgorov-Smirnov for \nthe first 6 weeks. Pre-op QoR-40 scores were not normally \ndistributed (K-S z=1.807, p<0.05) and week 2 QoR-40 scores \nwere also not normally distributed (K-S z=1.398, p<0.05). Based \non these observations we applied non-parametric statistical \ntests to the data. The Wilcoxon signed ranks test was used \nto compare scores with preoperative baseline and the Mann-\nWhitney U test was used to compare scores between treatment \nallocation groups at baseline. All analysis was according to \nintention to treat.\nPre-op (baseline scores) were compared between treatment \ngroups for all the questionnaires and subdomains using the \nMann-Whitney U test. There were significant differences \nat baseline for QoR-40: U=197, p=0.025 (LSH have a higher \nscore), e-PAQ-B(IBS): U=195, P=0.022 (LH group have a higher \nscore) and e-PAQ-B (Constipation); U=190, p=0.014 (LH \ngroup have a higher score) (Table 5). There were no statistically \nsignificant differences between treatment allocation groups \nat baseline with regards to CES-D scores, the remaining 17 \nsub-domain scores in e-PAQ and FSFI scores. This supports \nthe randomisation method which has resulted in largely \nhomogenous groups at baseline. Baseline characteristics for \nboth treatment groups and excluded patients are summarised \nin tables 2 & 3.\nVariable LH\n(n=25)\nLSH\n(n=25)\nNot randomized\n(n=19) P value\nAge in years 44 (38-46) 44 (40-47) 47 (42-49) 0.298\nBody mass index in kg/m2 26 (23-34) 29 (24-30) 27 (25-32) 0.841\nParity    \n     Nulliparous, n (%) 2 (8.0) 3 (12.0) 1 (5.3)  \n     Para 1 or 2, n (%) 13 (52.0) 12 (48.0) 13 (68.4) 0.607\n     Para 3 or more, n (%) 10 (40.0) 10 (40.0) 5 (26.3) 0.872\nPrevious CS     \n    None, n (%) 20 (80.0) 19 (76.0) 11 (57.9)  \n    One CS, n (%) 2 (8.0) 4 (16.0) 4 (21.1) 0.368\n    Two or more CS, n (%) 3 (12.0) 2 (8.0) 4 (21.1) 0.344\nTable 2. Baseline Characteristics\nVariable LH (n=25) LSH (n=25) P value\nPre-operative hemoglobin (g/dL) 13.8 (13.2-14.4) 13.1 (12.7-14.1) 0.063\nPost-operative hemoglobin (g/dL) 11.8 (11.3-12.5) 11.5 (10.9-12.4) 0.691\nOophorectomy    \n     Conserved, n (%) 7 (28) 10 (40) 0.551\n     Unilateral oophorectomy, n (%) 3 (12) 0 (0) 0.235\n     Bilateral oophorectomy, n (%) 15 (60) 15 (60) 1.000\nDuration of surgery (minutes) 105 (81-129) 80 (63-99) 0.014\nEstimated blood loss (mL) 200 (125-300) 100 (100-200) 0.011\nIn-patient stay (days) 2 (1-2) 1 (1-2) 0.326\nHistology of specimen    \n    Fibroids, n (%) 7 (28) 9 (36) 0.762\n    Adenomyosis, n (%) 4 (16) 5 (20) 1.000\n    Endometriosis, n (%) 1 (4) 2 (8) 1.000\n    Endometrial hyperplasia, n (%) 3 (12) 0 (0) 0.235\n    Normal histology, n (%) 10 (40) 9 (36) 1.000\nTable 3. Baseline Characteristics\n\nPage 9 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nThere was no significant difference between the groups at \nbaseline with respect to age, parity and previous caesarean \nsections. There was no significant difference at baseline with \nrespect to pre-operative haemoglobin concentration according \nto treatment allocation. Whether the patient was left with any \novaries following surgery was a clinical decision between the \npatient and the surgeon. However there was no significant \ndifference according to treatment allocation (chi square .802, \np=0.370 2 sided with 1df chart 3). \nIndications for hysterectomy are summarised in table 4\nThere was no difference at baseline with regards to primary \nindication for surgery and treatment allocation (chi square \n3.429, p=0.489 2 sided with 4 df chart 4). \nThese findings are supportive of the randomisation procedure \nemployed and we would plan to use this method in the \ndefinitive study.\n96% of the participants had treatment according to \nrandomisation; criterion for success was predefined as greater \nthan 95% treatment according to randomisation. Two patients \nrandomised to LH actually received LSH. In one case this \nwas a simple human error in interpreting the web generated \nrandomisation code. The second protocol violation was \nintentional and is dealt with in the discussion. The quantitative \nanalyses were according to intention to treat to correct for \nselection bias.\nA number of participants required additional procedures at \nthe time of surgery. In 4 cases adhesiolysis was performed. \nIn one case a transobturator tape continence procedure was \nperformed at the end of her surgery. Two women required \nremoval of contraceptive implants at the end of surgery. The \nadditional procedures were excluded from calculation of the \noperative time which was taken from the initial abdominal \n(umbilical excision) until the last abdominal skin suture. \nEstimated blood loss was statistically significantly less \nin the LSH group (100mls) compared to the LH group \n(200mls), p=0.011. However the volumes involved are not \nclinically important. Two participants received 2 unit blood \ntransfusions each. The first woman suffered a primary post-\noperative haemorrhage and was taken back to theatre 6 \nhours after the initial surgery. A repeat laparoscopy revealed \nbleeding from both uterine arteries and the vaginal vault. \nThe bleeding was controlled with a combination of bipolar \ndiathermy and laparoscopic extracorporeal sutures. She was \nnursed in the surgical High Dependency Unit overnight but \nmade an uneventful recovery and was discharged home on \nthe 3rd post-operative day. The second woman had a pre-\noperative haemoglobin concentraton of 9.2 g/dl secondary to \nhermenorrhagia.\nChi-Square Tests \n \nValue df \nAsymp. Sig. (2-\nsided) \nN of Valid \nCases \n50 \nPearson Chi-Square .802a 1 .370   \nContinuity Correctionb .357 1 .550   \nLikelihood Ratio .805 1 .370   \nFisher's Exact Test    .551 .276 \na. 0 cells (.0%) have expected count less than 5. The minimum expected count is 8.50. \nb. Computed only for a 2x2 table \n \nChart 3. Baseline Characteristics according to oophorectomy\nIndication1 * Randomisation Crosstabulation \nCount \n \nRandomisation \nTotal S T \nIndication1 Menorrhagia only 9 8 17 \nMenorrhagia and \ndysmenorrhea \n13 14 27 \nDysmenorrhea only 2 0 2 \nPelvic pain 1 2 3 \nIrregular bleeding 0 1 1 \nTotal 25 25 50 \nChi-Square Tests \n \nValue df \nAsymp. Sig. (2-\nsided) \nPearson Chi-Square 3.429a 4 .489 \nLikelihood Ratio 4.595 4 .331 \nN of Valid Cases 50   \na. 6 cells (60.0%) have expected count less than 5. The \nminimum expected count is .50. \n \nChart 4. Indication for Hysterectomy\n\nPage 10 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nOperative time was shorter in the LSH group (average 81 \nminutes) compared to the LH group (average 105 minutes) \np=0.014. Hospital stay was not significantly different according \nto treatment group (1-2 days).\nQuestionnaire data was complete at baseline with progressive \nattrition as the study progressed. At 6 weeks recovery data \n(QoR-40 and CES-D) was complete for 44 participants or \n88% in keeping with predefined requirement for feasibility \n(>85% complete data at 6 weeks). Beyond 6 weeks there was \nincremental missing data and at 12 weeks only 60% of recovery \ndata was complete (tables 6 and 7). We aimed to collect \ncomplete data in at least 75% of participants at 12 weeks. This \npart of the feasibility study was unsuccessful according to our \npredefined feasibility success criteria. Mean combined QoR-\n40 and CES-D scores are shown week by week in tables 6 and \n7. QoR scores fell below baseline but returned to preoperative \nlevels at 4 weeks. With regards to CES-D the mean peak scores \nare at post-op, week 1 and week 2 (greater than average score \nof 16 corresponding to clinical depression) with a rapid fall to \na score of, on average, 10 or less by week 5. The study is feasible \nwith regards to week by week data up to and including 6 weeks. \nAfter 6 weeks both QoR-40 scores and CES-D scores remained \nrelatively flat so the missing data form 6 weeks onwards does \nnot appear discriminatory. A second peak of CES-D scores was \nobserved at week 9 but did not reach the threshold of 16 which \ndefines depression in accordance with the authors of CES-D. \nThe time to fill in the short recovery questionnaires (QoR-40) \nand depression scores (CES-D) was, on average, less than 10 \nminutes.\nFilling in the paper version of e-PAQ and FSFI took over 30 \nminutes on average and a number of questionnaires were \nincompletely filled in. The data were complete at baseline. At 6 \nweeks 90% of e-PAQ and FSFI data were complete (in keeping \nwith the requirement to confirm feasibility. At 6 months 76% \nof e-PAQ and FSFI data were complete which was within the \nrequired 70% for success of feasibility.\nHowever, on closer inspection of the responses a number \nof points of confusion were discovered with the e-PAQ. The \npaper version of the e-PAQ is unacceptably cumbersome and \ndifficult to administer. The FSFI questionnaire is simpler than \nthe e-PAQ and as the name suggests is designed to assess \nsexual function in a reproducible way. The long term aspects \nof pelvic floor and sexual function were not reliably assessed in \nthis feasibility study. Reasons and possible improvements are \nexplored in the discussion.\nIn view of the fact that there were significantly higher QoR-\n40 scores at baseline in those randomised to LSH compared \nto those randomised to LH, we compared in allocation group \nscores with baseline using the Wilcoxon signed ranks test \n(Table 8). In the LSH group there is no significant difference \nLH LSH Excluded\nMenorrhagia only 8 32% 9 36% 4 21%\nMenorrhagia &Dysmenorrhea 14 56% 13 52% 9 47%\nDysmenorrhea only 0 0% 2 8% 1 5%\nPelvic pain 10 40% 10 40% 10 53%\nIrregular Bleeding 14 56% 14 56% 4 21%\nAbdominal mass 1 4% 3 12% 3 16%\nPremenstrual Syndrome 0 0% 2 8% 2 11%\nOvarian cyst 1 4% 1 4% 0 0%\nAnaemia 0 0% 0 0% 2 11%\nTable 4. Indications for hysterectomy\n\n\nPage 11 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nGroup\nPre-op\nPost-op\nWeek 1\nWeek 2\nWeek 3\nWeek 4\nWeek 5\nWeek 6\nWeek 7\nWeek 8\nWeek 9\nWeek 10\nWeek 11\nWeek 12\nMonth 6\nSubtotal DescriptivesMean\n187.2\n174.625\n173.4783\n178.0476\n183.913\n184.52\n187.0909\n188.28\n189.4737\n191.7647\n190.1176\n191.3889\n191.9412\n192.3333\n186.1538\nStandard devia\n-\ntion\n11.55422\n13.64077\n12.46402\n13.62159\n11.41336\n14.56915\n13.16167\n8.885944\n10.28142\n9.463941\n10.94236\n10.16418\n10.04658\n9.309493\n14.67904\nMedian\n190\n175.5\n172\n182\n186\n187\n187.5\n190\n193\n193\n194\n195\n193\n193\n193\nDifference from baselinep value (related samples Wil\n-\ncoxon signed ranks test)\n0.001\n0.001\n0.003\n0.322\n0.922\n0.434\n0.615\n0.371\n0.073\n0.552\n0.041\n0.102\n0.157\n0.388\nSignificant?\nY\nY\nY\nN\nN\nN\nN\nN\nN\nN\nY\nN\nN\nN\nTotal DescriptivesMean\n173.12\n164.3333\n166.1364\n163.8571\n173.1429\n175.7\n177.5789\n179.1\n179.6316\n174.7059\n167.2105\n176.7647\n177.4118\n166.7333\n180\nStandard devia\n-\ntion\n38.2724\n19.25722\n15.80023\n39.97535\n21.2068\n22.32087\n23.05625\n20.4628\n21.60044\n22.90678\n45.73666\n22.0015\n20.88378\n51.43716\n16.71077\nMedian\n181\n163.5\n169\n175\n182\n181\n184\n185.5\n185\n177\n177\n180\n185\n188\n181\nDifference from baselinep value (related samples Wil\n-\ncoxon signed ranks test)\n0.005\n0.001\n0.002\n0.046\n0.121\n1\n0.643\n0.635\n0.331\n0.422\n0.552\n0.981\n0.754\n0.138\nSignificant?\nY\nY\nY\nY\nN\nN\nN\nN\nN\nN\nN\nN\nN\nN\nTables 6 and 7 Combined QoR-40 and CES-D scores\nfrom baseline at 3 weeks and in the LH group there is no \nsignificant difference from baseline at 4 weeks. This suggests \nthat the advantage with respect to short-term recovery in the \nLSH group may only mean a difference of 1 week. Comparison \nof CES-D scores showed no discernible pattern (Table \n9).There were no statistically significant differences between \nthe treatment allocation groups according to whether the \nparticipant had any remaining ovary after the procedure or \nnot (Chart 3). There were no significant differences between \ntreatment allocation groups according to primary indication \nfor hysterectomy. These observations further support the \nrandomisation method used. \nRecovery and mood scores were analysed longitudinally and \ncompared with baseline according to whether any ovarian \ntissue was conserved or not. Recovery was not significantly \ndifferent according to ovarian status (statistically significant \nworse QoR-40 scores compared to baseline in both ovarian \nconservation and extirpation groups for post-op, week 1 and \nweek 2, table 10). However, there appeared to be a statistically \nsignificantly better CES-D score compared to baseline in those \nwomen undergoing oophorectomy at week 5, week 12 and \nmonth 6 (Table 11). \nThe 12th question in QoR-40 concerns ‘return to work or \nusual home activities’. We analysed this comparing each \nscore to baseline (chart 6) for this specific question using \nWilcoxon Signed Ranks test. Normal activity was denoted \nby a maximum score of 5. Our findings show a statistically \nsignificant difference from baseline in the LSH group until \n7 weeks whereas this persists in the LH group until 8 weeks. \nAlternatively the median score was consistently 5 (denoting \nnormal activity all of the time) from week 6 onwards in the \nLSH group whereas a median score of 5 was not consistently \nreached in the LH group until week 8 (Tables 12 and Chart 5). \nThe long questionnaire data (e-PAQ and FSFI) satisfied all the \ncriteria for feasibility with 100% complete data at baseline, 90% \ncomplete data at 6 weeks and 74% complete data at 6 months.\nThe 19 sub-domains from e-PAQ and overall FSFI scores were \ncompared to baseline at 6 weeks and 6 months (Tables 13- 32). \nScores for urinary incontinence and overall urinary quality of \nlife were statistically significantly better at 6 weeks in the group \nrandomised to LSH but this was not observed at 6 months.\nScores for bowel continence were also statistically significantly \nbetter at 6 weeks compared to baseline in the group randomised \nto LSH but this was not seen at 6 months.\nScores relating to vaginal pain were statistically significantly \nbetter than baseline at 6 weeks and 6 months in the group \nrandomised to LSH. Scores relating to vaginal prolapse \nsymptoms were statistically significantly better at 6 weeks \nin the group randomised to LH. Overall quality of life with \nrespect to vaginal symptoms was statistically significantly \nbetter at 6 weeks for both groups and at 6 months in the group \nrandomised to LH.\nSexual function and urinary symptoms were statistically \nsignificantly better than baseline at 6 weeks in the group \nrandomised to LSH but this was not observed at 6 months. \nSexual problems associated with vaginal symptoms were \nstatistically significantly better than baseline at 6 weeks in \nboth groups but not at 6 months. Dyspareunia was statistically \nsignificantly better than baseline at 6 weeks in the group \nrandomised to LSH but this was not observed at 6 months. \nOverall sexual function was statistically significantly better \n\nPage 12 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\ne-PAQ-U-Pain\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n6.67\n12.422\n.00\n \n9.78\n16.455\n.00\n \n8.15\n14.221\n.00\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.208\nN\n \n0.705\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n8.44\n14.084\n.00\n \n13.89\n16.071\n5.56\n \n16.16\n15.996\n11.11\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.098\nN\n \n0.4\nN\ne-PAQ-U-V oiding\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n2.66656\n5.226149\n.00\n \n2.66656\n5.753191\n.00\n \n4.44427\n8.253257\n.00\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n1\nN\n \n0.461\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n5.99976\n9.166300\n.00\n \n7.49970\n13.759082\n5.56\n \n16.16\n15.488053\n11.11\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.098\nN\n \n0.4\nN\ne-PAQ-U-Overactive B\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n10.33292\n20.451249\n.00\n \n6.66640\n13.607732\n.00\n \n9.44407\n13.312945\n.00\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.157\nN\n \n0.398\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n11.66620\n10.205799\n8.33300\n \n12.91615\n13.910975\n8.33300\n \n18.93864\n18.667002\n16.66600\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.805\nN\n \n0.758\nN\ne-PAQ-U-SUI\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n15.20076\n18.411867\n6.66700\n \n7.73372\n11.333900\n.00000\n \n11.11\n14.837\n.00\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.007\nY\n \n0.439\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n14.13404\n15.907933\n13.33400\n \n12.66730\n15.583045\n6.66700\n \n18.18\n24.055\n6.67\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.838\nN\n \n1\nN\nTable 13. Bladder Sub domain pain\nTable 14. Bladder Subdomain voiding\nTable 15. Bladder subdomain overactive symptoms\nTable 16. Bladder subdomain stress incontinence symptoms\n\nPage 13 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\ne-PAQ_U_Quality\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n11.11100\n18.975645\n.00000\n \n3.99996\n10.081868\n.00000\n \n8.14807\n14.220757\n.00000\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.028\nY\n \n1\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n10.66656\n15.869682\n.00000\n \n10.55545\n26.113649\n.00000\n \n22.22200\n36.174795\n11.11100\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.72\nN\n \n0.776\nN\ne-PAQ-B-IBS\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n23.67\n24.729\n16.67\n \n21.33248\n18.332600\n16.66600\n \n20.55473\n19.635457\n24.99900\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.97\nN\n \n0.36\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n37.00\n24.541\n33.33\n \n30.41545\n19.917714\n33.33200\n \n35.60464\n26.896598\n24.99900\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.5863\nN\n \n0.726\nN\ne-PAQ-B-Evacuation\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n15.80984\n11.882757\n14.28600\n \n11.61928\n10.743562\n9.52400\n \n10.47640\n9.891083\n9.52400\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.171\nY\n \n0.08\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n19.04800\n15.183737\n14.28600\n \n15.95270\n14.433529\n11.90500\n \n17.31636\n14.170087\n14.28600\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.592\nN\n \n 0.282\nN\ne-PAQ-B-Constipation\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n13.78\n15.140\n11.11\n \n16.44\n21.062\n11.11\n \n9.62953\n11.778758\n11.11100\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.458\nN\n \n0.68\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n23.56\n16.140\n22.22\n \n23.89\n18.478\n22.22\n \n20.20182\n20.974897\n11.11100\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.091\nN\n \n0.34\nN\nTable 17. Bladder subdomain overall quality Table 19. Bowel subdomain constipation\nTable 18. Bowel subdomain irritable bowel syndrome Table 20. Bowel subdomain evacuation\n\nPage 14 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\ne-PAQ_B-Continence\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n9.14304\n9.005931\n4.76200\n \n6.10\n6.073\n4.76\n \n9.52400\n14.510990\n4.76200\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.045\nY\n \n0.673\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n11.42880\n8.248026\n9.52400\n \n12.62\n11.693\n9.52\n \n15.15182\n11.028566\n14.28600\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.167\nN\n \n0.213\nN\ne-PAQ-B-Quality\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n4.89\n10.183\n.00\n \n2.67\n9.229\n.00\n \n6.67\n17.718\n.00\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.34\nN\n \n0.68\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n6.67\n8.486\n.00\n \n9.44\n14.543\n.00\n \n10.10\n13.567\n.00\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.141\nN\n \n0.67\nN\ne-PAQ-V-Capacity\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n1.78\n5.251\n.00\n \n.00\n.000\n.00\n \n1.48147\n3.909581\n.00000\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.102\nY\n \n0.317\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n6.22\n15.739\n.00\n \n3.33\n7.299\n.00\n \n5.05045\n9.113237\n.00000\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.414\nN\n \n 0.317\nN\ne-PAQ-V-Pain\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n17.66596\n14.296216\n16.66600\n \n8.99964\n11.764984\n8.33300\n \n11.66620\n14.014737\n8.33300\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.009\nY\n \n0.042\nY\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n18.66592\n17.226013\n16.66600\n \n9.58295\n12.173628\n8.33300\n \n16.66600\n18.256688\n8.33300\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.067\nN\n \n0.107\nN\nTable 21. Bowel subdomain continence Table 23. Vaginal subdomains Pain\nTable 22. Bowel subdomain overall quality Table 24. Vaginal subdomains Capacity\n\nPage 15 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\ne-PAQ_V-\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n3.66652\n7.248592\n.00000\n \n1.00\n3.664\n.00\n \n3.33320\n8.796293\n.00000\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.135\nN\n \n1\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n6.33308\n9.090230\n.00000\n \n2.08\n4.584\n.00\n \n3.78773\n7.784678\n.00000\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.046\nY\n \n0.146\nN\ne-PAQ-V-Quality\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n16.44428\n27.984137\n.00000\n \n1.78\n6.939\n.00\n \n3.70367\n9.072094\n.00000\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.005\nY\n \n0.108\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n24.88864\n33.221704\n11.11100\n \n5.56\n13.727\n.00\n \n2.02018\n4.494621\n.00000\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.026\nY\n \n0.026\nY\ne-PAQ-S-Sex and bowel\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n4.66648\n14.64808\n0\n \n0.66664\n2.307303\n0\n \n2.777667\n7.497495\n0\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.141\nN\n \n0.655\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n6.6664\n12.02765\n0\n \n2.4999\n6.677355\n0\n \n0\n0\n0\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.068\nN\n \n 0.102\nN\ne-PAQ-S-Sex and Urinary\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n12.99948\n26.1396\n0\n \n3.3332\n10.48546\n0\n \n2.222133\n5.864195\n0\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.043\nY\n \n0.144\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n7.99968\n14.12519\n0\n \n4.58315\n15.64227\n0\n \n15.15091\n28.82259\n0\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.715\nN\n \n0.273\nN\nTable 25. Vaginal subdomains Prolapse\nTable 26. Vaginal subdomains Quality\nTable 27. Sexual domains Sex and Urinary\nTable 28. Sexual domains Sex and bowel\n\nPage 16 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\ne-PAQ-S-Sex and Vagina\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n18.66592\n25.71555\n0\n \n4.9998\n11.02352\n0\n \n7.221933\n18.05636\n0\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.018\nY\n \n0.235\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n24.33236\n26.45208\n16.666\n \n11.24955\n24.2231\n0\n \n15.15091\n30.68947\n0\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.05\nY\n \n0.161\nN\ne-PAQ-S-Dyspareunia\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n17.86756\n21.66519\n13.334\n \n4.80024\n9.133222\n0\n \n9.778267\n13.53879\n6.667\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.001\nY\n \n0.053\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n17.86756\n21.23346\n13.334\n \n9.3338\n12.68668\n6.667\n \n15.75836\n22.16669\n6.667\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.063\nN\n \n0.128\nN\nFSFI\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n25.5125\n8.063137\n27.8\n \n18.91739\n11.44845\n19.3\n \n26.55\n9.054925\n31.55\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.033\nY\n \n0.139\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n22.3875\n11.0269\n24.25\n \n17.21053\n14.17282\n8.4\n \n26.86\n10.60107\n31.45\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.024\nY\n \n 0.017\nY\ne-PAQ-S-General\nGroup  Pre-op Week 6 Month 6\nSubtotal Descriptives\nMean\nStandard deviation\nMedian\n \n28.3322\n30.6174\n16.666\n \n14.33276\n15.31248\n16.666\n \n18.88813\n27.72106\n8.333\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.051\nN\n \n0.141\nN\nTotal Descriptives\nMean\nStandard deviation\nMedian\n \n33.66532\n28.30768\n24.999\n \n25.41565\n26.55504\n16.666\n \n16.666\n24.15133\n8.333\nDifference from \nbaseline\np value (related \nsamples Wilcoxon \nsigned ranks test)\nSignificant?\n \n \n \n \n0.086\nN\n \n0.014\nY\nTable 29. Sexual domains Sex and Vagina\nTable 30. Sexual domains Dyspareunia\nTable 31. Sexual domains -General\nTable 32. Overall FSFI score\n\nPage 17 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nthan baseline in the group randomised to LH at 6 months. \nWith regards to FSFI overall sexual function was statistically \nsignificantly better than baseline in both groups at 6 weeks but \nan improvement at 6 months was only observed in the group \nrandomised to LH.\nIn summary a double blind RCT to compare short and \nintermediate term outcomes of LSH with LH appears \nfeasible. Recruitment rates, adherence to protocol rates and \nresponse rates were in keeping with the predefined criteria \nfor feasibility. With regards to secondary outcomes, recovery \nappears quicker in LSH compared with LH, 3 weeks versus 4 \nweeks, with complete return to normal activities at 6 weeks \nin LSH versus 8 weeks in LH. Considering primary outcomes \nof a future definitive study urinary symptoms may be better \nfollowing LSH but prolapse symptoms appear better following \nLH. Overall sexual function appears improved with LH rather \nthan with LSH.\nWith regards to a power calculation for a future definitive \nstudy, if a difference of 5 in QoR-40 score is clinically \nsignificant, as has previously been established (Myles 2006), \nthen 186 women will be needed in either arm for a power of \n0.8 with α=0.05.\nDiscussion\nOur study shows that a double blind, randomised comparison \nof short and intermediate term outcomes following LH with \noutcomes following LSH is feasible but raises some important \nfactors to consider prior to roll out of a larger multicentre \nstudy. There are no published guidelines on what the criteria \nfor success of a feasibility study should be. Each feasibility \nstudy will have specific questions to answer in the subsequent \ndefinitive study. The criteria for success are based on whether \nthe definitive study can answer the research questions posed \nwithin a reasonable time frame and within reasonable \nresource constraints. We set our criteria for success based on \nwhat we would like to achieve in the definitive study in order \nto obtain meaningful results. If a feasibility study fails the \ninvestigators have the option to adjust the limits of time and \nresources for the proposed definitive study or abandon the \ndefinitive study. The methodology of the current study has not \nbeen used previously so no data were available to benchmark \nthe current study against. Many aspects of the feasibility study \nare, by definition, path finding and success criteria are based \non educated ‘guesstimates’.\nEvaluation of feasibility involves assessment of the processes \nthat are key to the success of the definitive study, consideration \nof the time and resource challenges that may occur during \nthe definitive study, human and data management problems, \nand lastly the scientific observations of treatment effect and \nvariance of effect [67]. \nProcess\nRecruitment was slower than anticipated. One contributory \nfactor for slower than anticipated recruitment was a change \nin the local Primary Care Trust’s referral and treatment \ncriteria for menstrual disorders. The result was a reduction \nin rate of referrals from primary care to secondary care for \nwomen suffering with menstrual disturbances than had been \nobserved prior to the new directive. Primary care physicians \nwere encouraged to try a number of conservative options for \nappropriate patients. The approach is recommended because \nit is in keeping with good clinical practice. The absolute \nnumber of referrals were not reduced but the time to enter the \nsecondary care pathway was prolonged.\nWith regards to the slow start to recruitment, this was while \nclinician’s working alongside the principal investigator were \nbecoming accustomed to the inclusion and exclusion criteria \nand were in the process of identifying eligible women to bring \nto the attention of the principal investigator. Once all the \nclinic staff were familiar with the eligibility criteria, the rate \nof recruitment significantly improved. This may be addressed \nby holding start-up meetings prior to the first recruitment \ndate to widely publicise the eligibility and recruitment criteria. \nThis would certainly be planned for any centre recruiting to \nthe definitive study. With the appropriate support it should be \npossible to recruit at least 1 woman a week from an average \ngynaecological caseload. As with all large multicentre studies \nit would be important to encourage collaboration from centres \nwith an established track record for clinical research. A \nprerequisite to success is a research philosophy that potential \ncontributing centres are signed up to; this is as, if not more, \nimportant as the resources and support to carry out the \nresearch [75]. \nThe exclusion rates for the study were acceptable and within \nthe predefined criteria for success of this feasibility study i.e. \nless than 30% approached were excluded from the study. Only \n8 women who were eligible and had surgery actually refused \nrandomisation from a total of 58 women who were eligible for \nrandomisation and who underwent surgery (13.8%). Given \nthat other than in Scandinavia [25], and some parts of the \nUnited States [76], rates of subtotal hysterectomy are less than \n10% of all hysterectomies, one might have assumed a greater \nreluctance to conserve the cervix. In the light of such emotive \nconcerns surrounding cervical cancer and the need for regular \nscreening [77] one might postulate that the majority of women \nin the United Kingdom would request removal of the cervix \nat the time of hysterectomy. We were pleasantly surprised \nthat, in our caseload, women with a benign indication for \nhysterectomy were largely open to the concept of cervical \nconservation despite warning them of an up to 20% chance \nof ongoing vaginal bleeding and the need to continue on \nthe cervical screening programme. Whether this would be \nobserved in other geographical areas of the United Kingdom is \nunclear but the prospect appears promising.\nThe inclusion and exclusion criteria were clear and did \nnot give rise to confusion. The woman who was found to be \nsuitable for vaginal hysterectomy and the woman whose cervix \nwas inaccessible making the study procedure impracticable \ncould have been excluded with a better assessment in the \nclinic setting. This would have avoided the disappointment \nto all concerned of exclusion after general anaesthetic. Strict \nadherence to the exclusion criteria should be possible with \ncareful assessment in the clinic setting.\nThe initial explanation of the study to eligible subjects was \ncarried out in the setting of a normal gynaecology clinic. \nThe explanation added, on average, 15 minutes to the total \nconsultation to allow the potential recruits some time to ask \nquestions. This is somewhat disruptive to the clinic but if we \nare aiming, on average, to invite 1-2 eligible women per clinic, \nthe overall disruption is minimal. The alternative would be to \nsimply identify eligible recruits in the clinic setting, provide \nthe information about the study and invite them back to a \ndedicated clinic set-up for the study. The latter approach has \nmerit in removing time-pressure but causes the inconvenience \nto the patient of an extra visit. For those women expressing \nan interest to participate, they were invited back at an interval \nof 4-6 weeks, on average, to inform the investigator of their \ndecision and provide informed consent. The interval visit \nwas arranged to coincide with an anaesthetic preassessment \nappointment to avoid inconvenience to the patient of an \n\nPage 18 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nextra visit. The enrolment visit took, on average, 30 minutes \nto allow the patient to ask questions and sign the appropriate \nconsents. This is longer than a routine surgical preassessment \nappointment by, on average, 15 minutes and reflects the time \nrequired to go through the research questionnaires in detail \nand allow time for questions. The latter process would be easier \nin a dedicated clinic but would add a visit with the associated \nresource implications and patient inconvenience. In any \ndefinitive study we would plan to cover public transport or \nmileage costs to the participants which is standard practice for \nmany phase III studies.\nThe randomisation procedure appears to have been successful \nat removing selection bias given the similarity between groups \nat baseline. The process of randomisation was simple to \nadminister and the only requirement was internet access in the \noperating theatre. Despite the simplicity 1 patient was treated \ninappropriately due to misinterpretation of the randomisation \ncode and represents a simple human error. The patient who \nwas initially excluded due to an injury to the transverse colon \nwas readmitted 3 months after the first surgery. She was \nrandomised to LH but during the course of the surgery, the size \nand shape of the uterus made LSH less technically challenging. \nGiven her history of surgical complication we opted to perform \nLSH to avoid unnecessary hazards. These protocol violations \nwere addressed by analysing the data according to intention to \ntreat. The randomisation procedure was otherwise robust. It is \nsomewhat cumbersome to wait until the initial laparoscopic \nsurvey had been completed prior to randomisation but this \nwas an important step to avoid randomisation of women in \nwhom both techniques were not technically feasible. There \nwas reliance on other members of the theatre team to perform \nthe randomisation and relay the information to the operating \nsurgeon. In the definitive study the surgeon should view the \ncomputer screen to reduce the risk of erroneous interpretation \nof the randomisation code.\nThe short questionnaires were relatively quick to fill in. \nThere did not appear to be any misunderstanding of the QoR-\n40, which sets out the question scores for all domains with \n1 signifying the worst possible recovery and 5 the best. The \nCES-D has 20 questions 16 of which score a maximum of 3 for \nsymptoms associated with depression and 4 questions with a \nminimum score of 0 for symptoms associated with depression. \nThe inversion of the scales were poorly understood and many \nrespondents had a tendency to circle a column of zeros even \nthough the symptoms were incongruent e.g. question 16 ‘I \nenjoyed life’ score zero corresponding to‘rarely or none of the \ntime’ and question 18 ‘I felt sad’ score zero corresponding to \n‘rarely or none of the time’. The CES-D has been validated but \nin view of the confusing questions we will consider alternative \nmeasures of mood in the definitive study such as the Women’s \nHealth Questionnaire [78] or the State-Trait Anxiety Index \n(STAI)[79]. The alternative measures of psychological welbeing \nhave been used in a previous RCT comparing day by day \nrecovery following STAH with TAH [21].\nRecovery data until the 6 week mark was complete in 88% of \nthose enrolled (greater than 85% complete data predefined as \nsatisfactory outcome). After 6 weeks there was a progressive fall \noff in completeness of data to 60% at 12 weeks. However, the \ndata up to 6 weeks appears discriminatory whereas data from \nweeks 7 to 12 does not; the data from week 7 to 12 was analysed \nby excluding missing data on a case by case basis. Our pilot \ndata show a fall in mean QoR-40 scores at post-op, weeks 1 to \n4 with return to mean pre-operative scores by week 4 (Table \n5). From week 5 onwards the QoR-40 scores are relatively flat \nalthough the data must be viewed with caution as the missing \ndata exceeds 30% from week 8 onwards.  The week by week \ndata between 7 and 12 weeks appears non-discriminatory \nboth within the treatment group longitudinally and between \nthe treatment groups at weekly intervals. This data does not \nappear to add value to the analysis and could be omitted in the \ndefinitive study. With regards to the specific question regarding \nreturn to normal activities in QoR-40 (12th question), there \nwas no significant difference from baseline by 6 weeks in the \nLSH group and by 8 weeks in the LH group. Therefore a case \ncan be made to continue week by week recovery and mood \ndata until 8 weeks in any future definitive study.\nResources\nThe paper version of e-PAQ is rather cumbersome to \nadminister. There are 4 domains and in the paper version it is \nnecessary to answer every question which takes 30 minutes, on \naverage, but is rather confusing. For example if the answer to \nquestion U1a: do you have any bladder problems or concerns? \nis no, none of the next 12 pages are relevant. However in the \npaper version there was a natural tendency to answer every \nquestion which is confusing. Conversely the electronic version \nis very user friendly and intuitive such that if the answer to \nU1 a is no then the participant is automatically taken to the \nnext domain. The e-PAQ is used in many urogynaecology \nclinics routinely. The electronic version produces graphical \nrepresentations of patient symptoms in four domains. Namely \nthese are urinary, bowel, vaginal and sexual function domains. \nThe e-PAQ is particularly helpful in assessing changes in each of \nthe domains following an intervention such as physiotherapy, \ndrug therapy or surgery. The electronic version of e-PAQ is \nan essential part of any assessment of pelvic floor function in \nlongitudinal studies. We would have liked to have used the \nelectronic e-PAQ for the feasibility study but cost constraints \ndid not allow this. There is currently an on-line format such \nthat participants can input the data in the comfort of their own \nhomes. This would certainly be the way forward for any future \ndefinitive study looking at a comprehensive assessment of a \nwoman’s pelvic function symptoms.\nManagement\nInputting data onto an Excel spreadsheet was a painstaking \nand laborious process. On average it took the data handler \n1 hour and 15 minutes to input all relevant data from 1 \nparticipant. During the process several breaks were required \nto avoid erroneous data entry. Ideally the loading of the data \nshould be automated electronically as in the electronic version \nof e-PAQ. This would reduce the time required and should be \nless prone to data transcription error. For any data that has \nto be entered manually a minimum of double data entry with \nexamination of incongruent entries is an established method \nof reducing errors.\nWith regards to missing data there is a well-established \nprincipal that the sooner a piece of missing data is chased the \nmore likely it is that the data will be completed.\nIn a busy clinical setting timely chasing of missing data is \nlabour intensive. Estimates from the current study suggest at \nleast 8 hours per week need to be assigned to chasing missing \nquestionnaires either by e-mail or by phone. Ideally reminder \nquestionnaires should be automated which would reduce the \ntime required to chase missing data. An investigator need only \nbe involved if there is no response to a predefined number of \nreminders e.g. 2. It is crucial to remember that participants \nare at complete liberty to ignore questionnaires and a balance \nmust be maintained between collecting complete data and \n\nPage 19 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nperception of bothersome irritation to participants. \nCollection of data at 6 weeks was relatively straight forward \nas this was the time of a scheduled post-operative visit to the \nclinic. At the 6 week milestone almost all participants were \nback to normal activity and most had returned to work. It is \nnot surprising that the timely completion of questionnaires \nprogressively fell after the 6 week post-operative milestone as \nmost participants had returned to their busy lives.\nScientific outcomes\nThe treatment allocation groups were similar at baseline. Our \npilot data appear to confirm faster recovery and faster return \nto normal activities following LSH compared to LH. The \ndifference, on average, appears to be in the order of 1-2 weeks. \nThis is probably an important difference if it allows women \nto return to work 2 weeks earlier following hysterectomy. \nObservational studies have suggested return to work within \n10 – 14 days following LSH [80,81] which was echoed in \na prospective RCT comparing LSH with hysteroscopic \nendometrial resection [61]. Anecdotally one of the women who \nwas randomised to and underwent LSH in the current study \nwas riding a horse within 10 days of LSH (against medical \nadvice) with no apparent ill effects. \nPerhaps the most important single question with regards to \npost-operative recovery is when is a patient able to return to all \nnormal activity including work ‘all of the time’. This is the 12th \nquestion in the QoR-40 and the results are shown in tabular \nand graphical form (Table 12, Chart 4). Our results show a 1-2 \nweek advantage with return to complete normal activity in the \nparticipants randomised to LSH.\nSomewhat surprisingly the differences in QoR-40 scores to pre-\ntreatment were similar whether ovarian tissue was conserved \nor not. Previous investigators have shown worse quality of \nlife if premenopausal women undergo BSO at the time of \nhysterectomy [82]. At 6 months, the BSO group demonstrated \nless improvement than women with ovarian conservation on \nscales for body image), sleep problems and the SF-36 Mental \nComponent Summary. The women undergoing BSO were on \naverage older than the conservation group in the Teplin study \nand the observed differences were no longer present at 2 years.\nSome women in the current study had cyclical symptoms \nprior to surgery particularly in the progestogenic phase of the \nmenstrual cycle. Extirpation of the ovaries reliably abolishes \nthe menstrual cycle and one might expect an advantage with \nrespect to progestogenic symptoms. Any potential advantage \nof removing the ovaries might be negated due to the onset \nof vasomotor symptoms. The latter may be reliably addresed \nwith appropriate oestrogen replacement which was offered to \nall women who were having their remaining ovaries removed. \nA large retrospective study has shown poorer psychosexual \nhealth 5 years after hysterectomy by any method which was \nworst of all in the women who had their ovaries removed [83]. \nIn the McPherson study hormone replacement therapy was not \nassociated with uniform beneficial effects in the women who \nhad undergone BSO at the time of hysterectomy.\nGiven that cyclical symptoms have a significant psychological \ncomponent one may have expected an observed advantage \nin mood in the women who had their ovaries removed. \nStatistically significant better CES-D scores were observed \nat week 5, week 12 and month 6 in the women who had their \novaries removed which is suggestive of an advantage to some \nwomen. Regardless of the findings the decision to remove \novaries will remain a clinical decision which is complex and \nmultifactorial. The only randomised study of LSH and TLH \nwith ovarian conservation designed specifically to investigate \npsychosocial outcomes showed no difference in both groups \n[29] but hysterectomy by either method resulted in reduction \nin abdominal pain and some improvement in sexual function. \nThe CES-D questionnaire in the current study demonstrated \na number of limitations and we would propose alternatives as \nmentioned earlier in the discussion.\nThe only RCT comparing recovery following LSH and TLH \nhas not shown any significant differences [30]. However, \nthe Italian study has a number of limitations. A total of 529 \nwomen were screened of whom 154 premenopausal women \nwith symptomatic menses and/or leiomyomata were assessed \nas eligible. Only 141 of those eligible agreed to randomisation \nbut there is no explanation regarding the 388 women who \nwere excluded. This may represent selection bias. In 12 cases \nthe participants did not receive the treatment they were \nrandomised to due to technical/clinical reasons. Whether \noutcome measures were analysed according to intention to \ntreat is not clear. Assessment of post-operative recovery is not \ndetailed so the validity of the tool is unclear. Moreover the \nparticipants were assessed at 3 monthly intervals for 2 years. If \nrecovery to full normal activity occurs within a matter of weeks, \nfar more frequent assessments would be required to show a \ndifference. Our feasibility study used validated instruments \nat weekly intervals. Perhaps daily assessment would be more \ndiscriminatory as used by Persson et al in their comparison of \nrecovery following SAH and TAH [20]. Since the current study \nwas designed Kirsten Kluivers and colleagues have compared \nthe QoR-40 and 2 other instruments for assessment of post-\noperative recovery [84]. They concluded that the Recovery \nIndex-10 (RI-10) should be the recommended instrument to \nmeasure short term post-operative recovery. We would aim \nto use the RI-10 in any future studies to assess recovery from \nsurgery which appears simpler to administer and more reliable.\nDetailed analysis of the e-PAQ and FSFI results have shown \na number of interesting findings. The return rates were in \nkeeping with prerequisites for feasibility. We obtained 100% \nreturns at baseline, 90% at 6 weeks and 74% at 6 months. The \nreturns were facilitated because the majority of participants \nagreed to complete the long questionnaires while they were \npresent at the clinic (pre-op visit, post-op visit, sign off visit). \nThe sign off visit was extra to standard clinical practice and \nwas offered on a voluntary basis. The 6 month returns were \ncomprised of 70% who chose to attend and only 4% (2 patients) \nwho responded by post. In the definitive study we would plan \nto routinely add in the 3rd visit and maintain the possibility to \nsend questionnaires at longer intervals, for example annually. \nThe web based e-PAQ interface would facilitate this longer term \nreview and allow women to fill in data on-line in the comfort \nof their own homes. There is an assumption around familiarity \nwith use of a computer screen but access and tuition could be \nprovided to the small minority who lack this. Strategies to \ninclude non-English speaking participants and those with \nimpaired sight would need to be considered and is beyond the \nscope of this discussion.\nThe e-PAQ paper version was somewhat confusing to the \nparticipants as discussed earlier in the process section. As such \nthe results should be viewed with some caution.\nThere appeared to be some benefit to the participants \nrandomised to LSH with regards to quality of life and urinary \n\nPage 20 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nsymptoms, particularly stress incontinence. Limited dissection \nof the bladder in LSH compared to LH has long been postulated \nas reducing subsequent urinary symptoms [26] but the findings \nhave not been substantiated for the abdominal approach to \nsub-total hysterectomy. This would be an important long term \noutcome of the definitive study.\nSimilarly there appeared to be some advantage at 6 weeks to the \ngroup randomised to LSH with regards to bowel continence. \nThe mechanism is more complex than the dissection issue but \nthe effect may not be real as this was not seen at 6 months and \ndid not appear to effect quality of life.\nThere appeared to be less vaginal pain in the group assigned \nto LSH compared to baseline at 6 weeks and 6 months. No \nsignificant reduction in vaginal pain was observed in the group \nassigned to LH. The latter however appeared to have lower \nvaginal prolapse symptoms which was accompanied by an \nimprovement in overall quality of life. Greater rates of prolapse \nhave previously been reported following SAH compared with \nTAH [17,27] which was contrary to the postulated greater \nsupport when the uterosacral ligaments and pericervical ring \nare left intact. This would be an important secondary outcome \nof the definitive study.\nThere appeared to be significant improvement in all sexual \nfunction domain scores at 6 weeks in the group assigned \nto LSH compared to baseline except in the sex and bowel \nsubdomain but this did not translate to an improvement \nin general sexual matters. In the group assigned to LH an \nimprovement was observed at 6 months for the general sexual \nmatters subdomain.\nThe FSFI scores show overall improvement in the group \nassigned to LH at both 6 weeks and 6 months whereas an \nimprovement was only observed at 6 weeks for the group \nassigned to LSH. This is the opposite to what has been postulated \n[9] and appears to have been the major drive towards subtotal \nhysterectomy in Scandanavia. This is certainly an important \noutcome to include in the definitive study and would allow \ncorrelation between the FSFI and e-PAQ with regards to sexual \nfunction. Perhaps the real value of the e-PAQ is to assess the \nindividuals response to treatment of pelvic symptoms which \ncan be represented graphically and inform discussions \nbetween clinicians and their patients. The electronic version \nwith web based interface would be essential to administer a \nlarge multicentre study. \nCaution should be excercised when interpreting the results of \nfeasibility studies. The observations may not be generalisable. \nA major weakness of the current study is that we evaluated only \none centre or, more precisely, 1 surgical team. The challenges \nof replicating uniform protocols in more than 1 centre are \nrecognised [85]. The advantage of increasing study power to \nreduce the risk of a type II error is at the cost of potential loss \nof uniformity [86]. Robust measures are required to assure \ndata quality. One of the major criticisms of the eVALuate study \n[87] was the lack of standardisation of techniques leading to a \npotential comparison of ‘apples with pears’.\nProblems with quality assurance and strict adherence to \nstudy protocol are proportional to the number of centres in a \nmulticentre trial. Increasing the number of centres improves \nrecruitment rates but requires careful management and a \nstructured approach [88]. Based on our power calculation from \nthe QoR-40 data a definitive study would require 186 women \nin each arm. We would recommend a maximum of 4 centres \nall of which should have a track record of regularly performing \nLSH and LH; a track record in participating in research trials \nwould also be desirable. \n‘Cherry picking’ centres with an established track record \nof collaboration in good quality research carries other risks. \nUsing such centres restricts the setting such that interventions \nare carried out by enthusiasts. Enthusiasts are likely to have \na thorough knowledge of the intervention under study, be \nfamiliar with good clinical practice and biostatistics but may \nhave preformed ideas of which intervention is better (bias).\nThe results may not be representative of the ‘average’ district \ngeneral hospital. Perhaps the correct setting for the definitive \nstudy would include 2 centres of excellence and 2 district \ngeneral hospitals. \nFurthermore, study participants may be inherently different to \nnon-participants [89] and the results may not be generalisable \nto the non-study population. The study participants represent a \nsample which should be representative of the larger population \nto confer external validity. A number of epidemiological \nstudies have shown that study participants may enjoy better \ngeneral health than non-participants due to motivation, better \nawareness of health nutrition and, as yet, undefined factors \n[90,91]. Reliable randomisation and blinding is the method \nemployed to correct for potential bias. \nIn this feasibility study the randomisation and blinding \nprocedures were simple to administer and appear reliable.\nDuring the time when this feasibility study was being \nplanned, the Author’s standard practice was to offer either \nLH or LSH for those women requiring hysterectomy for a \nbenign indication and in whom there was no history of high \ngrade cervical intraepithelial neoplasia. Since conducting the \nfeasibility study the Author has changed to Total Laparoscopic \nHysterectomy (TLH) instead of (LH) as the method of choice \nfor removing both corpus and cervix. A large proportion of \nthe Author’s caseload is made up of postmenopausal women \nwith low grade endometrial carcinoma. The women tend to \nhave high body mass indices and poor vaginal access. TLH \nis an elegant method to avoid a struggle to remove the uterus \nvaginally in such patients. Having become proficient at this \ntechnique this is now the method employed for all women who \nelect to have the uterine corpus and cervix removed and who are \nnot suitable for simple vaginal hysterectomy. When planning \nthe definitive study we would aim to compare primary and \nsecondary outcomes between LSH and TLH. Observational \ndata from Medway Maritime Foundation Hospital suggest \ncomparable short term recovery. Retrospective studies of \nothers suggest some short term advantages of LSH compared \nto TLH [92,93] but this appears to be at the cost of greater long \nterm complications in the LSH group, largely related to the \ncervical stump [92,94]. Although bleeding from the cervical \nstump may be present in up to 24% of those undergoing \nLSH [95] the vast majority of patients found this a minor \ninconvenience (median VAS bothersome score zero) and 92% \nof respondents were satisfied or very satisfied with the surgery. \nIn a retrospective comparison of TLH and LSH with regards \nto reoperation, method specific indications for reoperation \nwere observed in 2.7% of the LSH group (late reoperation for \nextirpation of cervical stump) and 0.7% of TLH group (early \nreoperation to repair vaginal vault dehiscence) Einharrson and \ncolleagues [96] have compared LSH and TLH prospectively \nand concluded advantages in the LSH group in terms of both \nphysical and psychological quality of life measures. However, \nin their study this did not translate to any advantage with \n\nPage 21 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nrespect to return to normal activities post-surgery. The current \nfeasibility study remains very pertinent as the recruitment \nprocess, trial management and practicality of the instruments \nused were the main focus. \nThe power calculation presented in the results may not be \nappropriate as the magnitude of observed differences may be \ndifferent when comparing TLH and LSH.\nPower of the definitive study needs to be set such that a \nclinically important difference can be reliably detected. This is \ndependant upon the research hypothesis. The original research \nhypothesis was that there is a clinically important difference in \ntime to full recovery in women undergoing LSH compared to \nthose undergoing LH.\nOur new research hypothesis would be that there is a clinically \nimportant difference in time to full recovery in women \nundergoing LSH compared to those undergoing TLH.\nWe estimate the difference in time to recovery from LSH \ncompared with TLH to be 30% less in magnitude than \nthe difference observed between LSH and LH (based on \nassumptions following local observations of surrogate markers \nincluding analgaesic requirement and time to mobilisation). \nAs such we would propose multiplying the numbers required \nto treat by a factor of 1.3 to avoid a type II error. The definitive \ndouble blind RCT to compare LSH with TLH would require \n240 women in each arm if power is kept at 0.8 and α at 0.05. It \nwould be prudent to increase this to 275 to allow for 12% drop \nout rate (88% returned recovery questionnaires at 6 weeks). \nTotal recruits needed would be 550\nA single blind RCT of LSH versus TLH is currently being \nrecruited for in the Brigham Women’s Hospital under the \nsupervision of Chief Investigator Jon Einarsson (www.\nclinicaltrials.gov/ct2/show/study/NCT00734812?term=Brig\nham+Women's+Laparoscopic+Hysterectomy+trial&rank=1). \nRecruitment started in May 2008 and the study is due to \ncomplete in October 2013. Primary outcomes are return to \nnormal activities, measured by daily diary, with an expected \nrange of 3-6weeks. Secondary outcomes include urinary \nsymptoms assessed by 3IQ and sexual function measured by \nFSFI. The trial is planned to recruit 172 women which in our \nopinion will be underpowered. \nA smaller RCT comparing LSH and TLH is due for \ncompletion of recruitment in December 2012 entitled ‘Long \nTerm Outcomes following Total Laparoscopic Hysterectomy \nand Laparoscopic Supracervical Hysterectomy’ (www.http://\nclinicaltrials.gov/ct2/show/NCT01289314?term=Laparoscop\nic+AND+Hysterectomy+AND+Lieng&rank=1). The planned \nrecruitment is for 62 patients (31 in each arm) with primary \noutcome measures of pain relief requirement and satisfaction \nwith the surgery. Based on the feasibility study presented the \nstudy will be underpowered with regards to post-surgical \nrecovery.\nConclusion\nObservational data suggest that in women undergoing \nlaparoscopic hysterectomy for a benign indication with no \nhistory of high grade cervical intra-epithelial neoplasia, \nconservation of the cervix is associated with faster recovery. \nThis was not confirmed in the only randomised comparison of \nLSH with TLH [30]. However the Italian study had a number \nof limitations as summarised in the discussion.\nNo randomised comparisons of LH versus LSH have been \nfound following an extensive search of the literature. We \npresent the results of a feasibility study of a double blind RCT \ncomparing recovery and mood following LSH with LH. \nA double blind randomised controlled trial to compare \nshort term outcomes and recovery following laparoscopic \nsupracervical hysterectomy with those following laparoscopic \nhysterectomy is feasible.\nRandomisation using a web based computer generated block \nrandomisation sequence is easy to use and results in relatively \nhomogenous groups.\nRecruitment, treatment and data collection can be achieved \nwithin 2 years of commencement for 50 patients from 1 \nsurgeon participant. \nReturn of 85% data at 6 weeks and 75% data at 6 months is \nachievable.\nReturn of short questionnaires are good in the first 6 weeks \nwith progressive drop in return rates to 60% at 12 weeks. Data \nfrom 8 to 12 weeks does not appear discriminatory and would \nbe omitted from the definitive study.\nThe data collected appear to be non-parametric following \nKomolgorov- Smirnov analysis. Mann Whitney U and \nWilcoxon Signed Ranks analysis is appropriate for quantitative \noutcomes.\nThe QoR-40 was a good choice to assess post-operative recovery \nbut appears to have been superceded by the RI-10. Conversely \nCES-D is confusing and alternative measures of mood such as \nthe WHQ or STAI would be preferred for the definitive study. \nLengthy paper questionnaires are confusing and electronic \nversions with an online interface should facilitate data quality. \nNone-the–less return rates of paper questionnaires are good if \nparticipants fill them in at a clinic attendance (90% at 6 weeks, \n74% at 6 months). The e-PAQ and FSFI are informative with \nregards to pelvic and sexual function. The e-PAQ may be most \nvaluable in assessing changes in pelvic function longitudinally \nin individuals following an intervention. Analysis may be \nrepeated at various intervals to assess, short, intermediate and \nlong term outcomes.\nSecondary outcomes of the feasibility study included \nquantitative analysis of QoR-40 scores and CES-D scores. \nSecondary outcomes suggest a 1-2 week advantage with respect \nto recovery from LSH versus LH, which is clinically important \nin terms of returning to normal activity including work. LSH \ntakes, on average, 25 minutes shorter operative time which is \nprobably important in terms of theatre time costs.\nLSH is associated with less blood loss but the volume (100mls \ndifference on average) is not clinically relevant.\nLSH may be associated with better outcomes with regards \nto urinary symptoms but LH appears to be associated with \nbetter outcomes with regards to post-operative symptomatic \nprolapse. No advantage was suggested with regards to \nsexual function and LSH but study design precludes direct \ncomparisons between treatment allocation groups. Indeed, \nfindings from this feasibility study suggest an advantage in the \ngroup allocated to LH with regards to sexual function.\nWe would plan to replicate this study as a multicentre \ndefinitive double blind RCT to compare outcomes following \ndifferent methods of laparoscopic hysterectomy. However, we \nwould recommend a comparison of LSH and TLH. TLH is now \nthe preferred method of removing both the uterine corpus and \ncervix at the Author’s main Hospital of practice. \nWhether conservation of the cervix at laparoscopic \n\nPage 22 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nhysterectomy confers any short, intermediate or long term \nbenefit remains unclear and the definitive study is essential to \naddress this important clinical question. \nFindings from this feasibility study will be used to inform a \ngrant application for the definitive study. In order to show a \ndifference we guesstimate needing to recruit 550 women from \nan estimated total of 4 centres. \nTwo much smaller trials are recruiting at the moment at \nBrigham women’s hospital, Boston Massachusetts USA \n(estimated n=172) and the University Hospital in Oslo, Norway \n(estimated n=62). From the data presented in this feasibility \nstudy the trials are likely to be significantly underpowered to \ndetect any differences with regards to post-surgical recovery \nand return to normal activities.\nAcknowledgements\nThis study was supported by a research grant from JOHNSON \n& JOHNSON MEDICAL LIMITED.\nThanks to my unit at Medway Maritime Hospital for providing \nthe environment and the wealth of clinical material to study.\nI am grateful to Hany Wisa, my speciality Doctor for his \ninvaluable help with developing an online interface for \nquestionnaires, data transcription and chasing missing \nreturns.\nFinally I wish to thank all the women who took part in the \nstudy and painstakingly filled in the questionnaires. Ladies, \nwithout you, none of this would have been possible.\nReferences\n1. Clay C. Observations on Ovariotomy statistical and practical. \nAlso a successful case of entire removal of the uterus. Trans \nObstet Soc Londonl. 1863 ;5:58-74\n2. Sutton C. Hysterectomy: a historical perspective . Baillière’s \nClin. Obstet. Gynaecol.1997;11(1):1-22 \n3. Pfannenstiel HJ. Uber die Vortheile des suprasymphysären \nFascienquerschnitts für die gynäkologischen Köliotomien, \nzugleich ein Beitrag zu der Indikationsstellung der \nOperationswege. Sammlung Klinischer Vorträge, Gynäkologie \n(Leipzig), vol.97 pp. 1735-1756, 1900. Am J Obstet Gynecol. \n1974;118(3):427..\n4. Richardson EH. A Simplified Technique for Abdominal \nPanhysterectomy. Surg Gynecol Obstet. 1929;48:248-53.\n5. HESonline, 2010-2011 The information Centre for health and \nsocial care, Northgate information Solutions. Annual Update\n6. Kilkku P, Gronroos M, Hirvonen T, Rauramo L. Supravaginal \nuterine amputation vs hysterectomy. Effects on libido and \norgasm. Acta Obstet Gynecol Scand. 1983;62:147-52\n7. Tervilae L. Carcinoma of the Cervical Stump. Acta Obstet Gynecol \nScand. 1963;42:200-210. doi:10.3109/00016346309157881\n8. Petersen LK, Mamsen A, Jakobsen A. Carcinoma of the cervical \nstump. Gynaecologic Oncology. 1992;46(2): 199-202.\n9. Kilkku P, Gronroos M. Peroperative Electrocoagulation of \nEndocervical Mucosa and Later Carcinoma of the Cervical \nStump. Acta Obstet Gynecol Scand. 1982;61(3):265-67\n10. Kilkku P. Supravaginale uterine amputation versus \nhysterectomy: effect on coital frequency and dyspareunia. Acta \nObstet Gynecol Scand. 1983;62:141-145.\n11. Nathorst-Böös J, von Schoultz B. Psychological reactions and \nsexual life after hysterectomy with and without oophorectomy. \nGynecol Obstet Invest. 1992;34(2):97-101.\n12. Zobbe V, Gimbel H, Andersen BM, et al. Sexuality after \ntotal vs. subtotal hysterectomy. Acta Obstet Gynecol Scand. \n2004;83(2):191-196.\n13. Gorlero F, Lijoi D, Biamonti M, et al. Hysterectomy and women \nsatisfaction: total versus subtotal technique. Arch Gynecol \nObstet. 2008;278:405-410.\n14. Kilkku P. Supravaginal uterine amputation versus hysterectomy \nwith reference to subjective bladder symptoms and incontinence. \nActa Obstet Gynecol Scand. 1985;64(5):375-379.\n15. Gimbel H, Zobbe V, Andersen BA, et al. Randomised controlled \ntrial of total compared with subtotal hysterectomy with 1 year \nfollow-up results. BJOG. 2003;110:1088-1098.\n16. Thakar R, Ayers S, Clarkson P, et al. Outcomes after total \nversus subtotal abdominal hysterectomy. N Engl J Med. \n2002;347(17):1318-1325.\n17. Thakar R, Ayers S, Clarkson P, Stanton S, Manyonda I. \nHysterectomy improves quality of life and decreases psychiatric \nsymptoms: a prospective and randomised comparison of total \nversus subtotal hysterectomy. BJOG. 2004;111:1115-1120.\n18. Thakar R, Srivastava R, Ayers S, Manyonda I. Removing the \ncervix at hysterectomy—an unnecessary intervention? Obstet \nGynecol. 2008;112:1262-1269.\n19. Rudigoz RC, Gonnet C, Rochet Y, Dargent D, Brémond A. \nProlapse after hysterectomy: a study of 45 cases (author's transl). \nJ Gynecol Obstet Biol Reprod (Paris). 1981;10(3):241-247.\n20. Persson P, Brynhildsen J, Kjølhede P; Hysterectomy Multicentre \nStudy Group in South-East Sweden. Short-term recovery after \nsubtotal and total abdominal hysterectomy—a randomised \nclinical trial. BJOG. 2010;117(4):469-478.\n21. Persson P, Brynhildsen J, Kjølhede P; Hysterectomy Multicentre \nStudy Group in South-East Sweden. A 1-year follow up of \npsychological wellbeing after subtotal and total hysterectomy-\n-a randomised study. BJOG. 2010;117(4):479-487. doi:10.1111/\nj.1471-0528.2009.02467.x \n22. Learman LA, Summitt RL Jr, Varner RE, et al. A randomized \ncomparison of total or supracervical hysterectomy: surgical \ncomplications and clinical outcomes. Obstet Gynecol. \n2003;102(3):453-462. doi:10.1016/s0029-7844(03)00664-1\n23. Lethaby A, Ivanova V, Johnson NP. Total versus subtotal \nhysterectomy for benign gynaecological conditions. Cochrane \nDatabase Syst Rev. 2006;(2):CD004993. Published 2006 Apr 19. \ndoi:10.1002/14651858.CD004993.pub2.\n24. Culhed S, Rybo G, Carlsson P, et al.Hysterectomy? Causes, \npractice andalternatives . Konsensuskonferens. Stockholm, \n1993.\n25. Gimbel H, Settnes A, Tabor A. Hysterectomy on benign \nindication in Denmark 1988-1998. A register based trend \nanalysis. Acta Obstet Gynecol Scand. 2001;80(3):267-272.\n26. Lalos O, Bjerle P. Bladder wall mechanics and micturition \nbefore and after subtotal and total hysterectomy. Eur J Obstet \nGynecol Reprod Biol. 1986;21(3):143-150. doi:10.1016/0028-\n2243(86)90028-626]\n27. Gimbel H. Total or subtotal hysterectomy for benign uterine \ndiseases? A meta-analysis. Acta Obstet Gynecol Scand. \n2007;86(2):133-144. doi:10.1080/00016340601024716\n28. Lethaby A, Mukhopadhyay A, Naik R. Total versus subtotal \nhysterectomy for benign gynaecological conditions. Cochrane \nDatabase Syst Rev. 2012;(4):CD004993. Published 2012 Apr 18. \ndoi:10.1002/14651858.CD004993.pub3.\n29. Flory N, Bissonnette F, Amsel RT, Binik YM. The psychosocial \noutcomes of total and subtotal hysterectomy: A randomized \ncontrolled trial. J Sex Med. 2006;3(3):483-491. doi:10.1111/\nj.1743-6109.2006.00229.x \n30. Morelli M, Noia R, Chiodo D, et al. Laparoscopic supracervical \nhysterectomy versus laparoscopic total hysterectomy: a \n\nPage 23 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\nprospective randomized study. Minerva Ginecol. 2007;59(1):1-\n10.\n31. Litynski I. Laparoscopic Appendicectomy. JSLS. 1998;2:309-313\n32. Reynolds K. Laparoscopic cholecystectomy. JSLS. 201;5:89-94\n33. Reich H, DeCaprio J, McGlynn F. Laparoscopic hysterectomy. J \nGynecol Surg. 1989; 5:213-15.\n34. Garry R. The future of hysterectomy. BJOG. 2005;112:133-39\n35. Temkin O. Soranus’ Gynecology. Johns Hopkins Press, \nBaltimore. 1956.\n36. Donnez J, Squifflet J,Jadoul P, Smets M. Results of eVALuate \nstudy of hysterectomy techniques: High rate of complications \nneeds explanation BMJ. 2004;328:642-643\n37. Brummer TH, Seppälä TT, Härkki PS. National learning curve \nfor laparoscopic hysterectomy and trends in hysterectomy \nin Finland 2000-2005. Hum Reprod. 2008;23(4):840-845. \ndoi:10.1093/humrep/den006\n38. Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry \nR. Surgical approach to hysterectomy for benign gynaecological \ndisease. Cochrane Database Syst Rev. 2006;(2):CD003677. \nPublished 2006 Apr 19. doi:10.1002/14651858.CD003677.pub3.\n39. Donnez O, Jadoul P, Squifflet J, Donnez J. A series of 3190 \nlaparoscopic hysterectomies for benign disease from 1990 to \n2006: evaluation of complications compared with vaginal and \nabdominal procedures. BJOG. 2009;116(4):492-500. doi:10.1111/\nj.1471-0528.2008.01966.x \n40. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach \nto hysterectomy for benign gynaecological disease. Cochrane \nDatabase Syst Rev. 2009;(3):CD003677. Published 2009 Jul 8. \ndoi:10.1002/14651858.CD003677.pub4.\n41. Mettler L, Semm K. Endoscopic classic intrafascial supracervical \nhysterectomy without colpotomy. Baillieres Clin Obstet \nGynaecol. 1994;8(4):817-829. doi:10.1016/s0950-3552(05)80058-\n6\n42. Lyons TL. Laparoscopic supracervical hysterectomy. Baillieres \nClin Obstet Gynaecol. 1997;11(1):167-179. doi:10.1016/s0950-\n3552(97)80056-9\n43. Schwartz RO. Laparoscopic hysterectomy. Supracervical vs. \nassisted vaginal. J Reprod Med. 1994;39(8):625-630.\n44. Donnez J, Nisolle M. Laparoscopic supracervical (subtotal) \nhysterectomy (LASH). J Gynecol Surg. 1993;9(2):91-94. \ndoi:10.1089/gyn.1993.9.91\n45. Oscarsson ME, Amer-Wåhlin I, Rydhstroem H, Källén K. \nOutcome in obstetric care related to oxytocin use. A population-\nbased study. Acta Obstet Gynecol Scand. 2006;85(9):1094-1098. \ndoi:10.1080/00016340600804530\n46. Lieng M, Istre O, Langebrekke A, Jungersen M, Busund \nB. Outpatient laparoscopic supracervical hysterectomy \nwith assistance of the lap loop. J Minim Invasive Gynecol. \n2005;12(3):290-294. doi:10.1016/j.jmig.2005.03.013.\n47. Kisic-Trope J, Qvigstad E, Ballard K. A randomized trial of day-\ncase vs inpatient laparoscopic supracervical hysterectomy. Am \nJ Obstet Gynecol. 2011;204(4):307.e1-307.e3078. doi:10.1016/j.\najog.2010.11.014 \n48. Erian J, Hassan M, Pachydakis A, Chandakas S, Wissa I, \nHill N. Efficacy of laparoscopic subtotal hysterectomy in the \nmanagement of menorrhagia: 400 consecutive cases. BJOG. \n2008;115(6):742-748. doi:10.1111/j.1471-0528.2008.01698.x.\n49. Chandakas S, Hill N, Erian J. A multicentered series of over 1000 \nlaparoscopic subtotal hysterectomies in the UK and Greece: The \nnew approach to hysterectomy. Gynecological Surgery. 2009; \nsuppl 16:S187-S188.\n50. Perron-Burdick M, Yamamoto M, Zaritsky E, et al. Same-day \ndischarge after laparoscopic hysterectomy. Obstetrics and \nGynecology. 2011;117(5): 1136-1141.\n51. Harmanli OH, Okafor O, Ayaz R, Knee A. Lidocaine jelly and \nplain aqueous gel for urethral straight catheterization and \nthe Q-tip test: a randomized controlled trial. Obstet Gynecol. \n2009;114(3):547-550. doi:10.1097/AOG.0b013e3181b43808\n52. Cipullo L, De Paoli S, Fasolino L, Fasolino A. Laparoscopic \nsupracervical hysterectomy compared to total hysterectomy. \nJSLS. 2009;13(3):370-375.\n53. Mousa NA, Jebrail MJ, Yang H, Abdelgawad M, Metalnikov P, \nChen J, Wheeler AR, Casper RF. Droplet-scale estrogen assays in \nbreast tissue, blood, and serum. Sci Transl Med. 2009;1(1):1ra2. \ndoi:10.1126/scitranslmed.3000105\n54. Mueler, 2009\n55. 55. Milad et al 2001\n56. Nam et al 2008\n57. Flory et al 2006\n58. Zobbe et al 2004\n59. Engh et al 2010\n60. Jugnet N, Cosson M, Wattiez A, et al Comparing vaginal or \ncoelioscopic total or subtotal hysterectomies. Prospective \nmulticenter study including 82 patients. Gynaecol Endoscl. \n2001;10:315-21\n61. Zupi E, Zullo F, Marconi D, et al. Hysteroscopic endometrial \nresection versus laparoscopic supracervical hysterectomy \nfor menorrhagia: A prospective randomised trial. AmJOG. \n2003;188:7-12\n62. Sesti F, Ruggeri V, Pietropolli A, et al. Thermal balloon ablation \nversus laparoscopic supracervical hysterectomy for the surgical \ntreatment of heavy menstrual bleeding: a randomized study. The \njournal of obstetrics and gynaecology research. 2011;37:1650-7\n63. Moher D, Schulz KF, Altman DG. The CONSORT statement: \nrevised recommendations for improving the quality of reports of \nparallel-group randomised trials. Lancet. 2001;357(9263):1191-\n1194. \n64. Everitt B. Medical Statistics from A to Z:A guide for clinicians \nand medical students. Cambridge University Press. Cambridge \n2, UK. 2006.\n65. Craig N, Dieppe P, McIntyre S, et al. Developing and evaluating \ncomplex interventions: the new Medical Research Council \nguidance. BMJ. 2008;337;1655\n66. Van Teijlingen ER, Hundley. The importance of reporting pilot \nstudies. Social Research update, 2001. http://sru.soc.srrey.ac.uk/\nSRU35.html\n67. Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the \nwhat, why and how [published correction appears in BMC Med \nRes Methodol. 2023 Mar 11;23(1):59. doi: 10.1186/s12874-023-\n01880-1]. BMC Med Res Methodol. 2010;10:1. Published 2010 \nJan 6. doi:10.1186/1471-2288-10-1 \n68. Bump RC, Mattiasson A, Bø K, et al. The standardization \nof terminology of female pelvic organ prolapse and pelvic \nfloor dysfunction. Am J Obstet Gynecol. 1996;175(1):10-17. \ndoi:10.1016/s0002-9378(96)70243-0\n69. Garry R, Reich H, eds. Laparoscopic Hysterectomy. London, \nUK: Blackwell Science Ltd; 1993:81-82.\n70. Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and \nreliability of a postoperative quality of recovery score: the QoR-\n40. Br J Anaesth. 2000;84(1):11-15. doi:10.1093/oxfordjournals.\nbja.a013366\n71. Radloff LS. The CES-D scale: A self-report depression scale \nfor research in the general population. AppliedPsychological \nMeasurement. 1977;1:385-401\n72. Kluivers KB, Riphagen I, Vierhout ME, Brölmann HA, de \nVet HC. Systematic review on recovery specific quality-of-\nlife instruments. Surgery. 2008;143(2):206-215. doi:10.1016/j.\nsurg.2007.08.017\n\nPage 24 of 24\nAbu Imad Hasib Ahmed.: Archives of Clinical Obstetrics and Gynecology Research. 2024, 3(1):1-24\nArch Clin Obs Gyn Res. (2023) Vol 3, Issue 1\n73. Radley SC, Jones GL, Tanguy EA, Stevens VG, Nelson C, \nMathers NJ. Computer interviewing in urogynaecology: \nconcept, development and psychometric testing of an \nelectronic pelvic floor assessment questionnaire in primary and \nsecondary care. BJOG. 2006;113(2):231-238. doi:10.1111/j.1471-\n0528.2005.00820.x.\n74. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function \nIndex (FSFI): a multidimensional self-report instrument for \nthe assessment of female sexual function. J Sex Marital Ther. \n2000;26(2):191-208. doi:10.1080/009262300278597 \n75. Prescott RJ, Counsell CE, Gillespie WJ, et al. Factors that limit \nthe quality, number and progress of randomised controlled \ntrials. Health Technol Assess. 1999;3(20):1-143.\n76. Sills et al 1998\n77. Fylan 1998\n78. WHQ Hunter 2000\n79. Speilberger et al 1970\n80. Sarmini et al 2005\n81. Lyons 2007\n82. Teplin V, Vittinghoff E, Lin F, Learman LA, Richter HE, \nKuppermann M. Oophorectomy in premenopausal women: \nhealth-related quality of life and sexual functioning. \nObstet Gynecol. 2007;109(2 Pt 1):347-354. doi:10.1097/01.\nAOG.0000252700.03133.8b\n83. McPherson K, Herbert A, Judge A, et al. Psychosexual health \n5 years after hysterectomy: population-based comparison with \nendometrial ablation for dysfunctional uterine bleeding. Health \nExpect. 2005;8(3):234-243. doi:10.1111/j.1369-7625.2005.00338.x \n84. Kluivers KB, Hendriks JC, Mol BW, et al. Clinimetric properties \nof 3 instruments measuring postoperative recovery in a \ngynecologic surgical population. Surgery. 2008;144(1):12-21. \ndoi:10.1016/j.surg.2008.03.027\n85. Fleiss J. The Design and Analysis of Clinical Experiments. John \nWiley and Sons Inc. 1999.\n86. Vierron and Giraudeau 2009\n87. Garry R, Fountain J, Mason S, et al. The eVALuate study: two \nparallel randomised trials, one comparing laparoscopic with \nabdominal hysterectomy, the other comparing laparoscopic with \nvaginal hysterectomy. BMJ. 2004;328(7432):129. doi:10.1136/\nbmj.37984.623889.F6 \n88. Farrell B, Kenon S, Shakur 2010. Trials;8;78\n89. Manjer et al 2001\n90. Rosengrun et al 1987\n91. Madsen et al 2007\n92. van Evert JS, Smeenk JM, Dijkhuizen FP, de Kruif JH, Kluivers \nKB. Laparoscopic subtotal hysterectomy versus laparoscopic \ntotal hysterectomy: a decade of experience. Gynecol Surg. \n2010;7(1):9-12. doi:10.1007/s10397-009-0529-8.\n93. Harmanli OH, Tunitsky E, Esin S, Citil A, Knee A. A comparison \nof short-term outcomes between laparoscopic supracervical and \ntotal hysterectomy. Am J Obstet Gynecol. 2009;201(5):536.e1-\n536.e5367. doi:10.1016/j.ajog.2009.07.048 \n94. Okaro EO, Jones KD, Sutton C. Long term outcome \nfollowing laparoscopic supracervical hysterectomy. BJOG. \n2001;108(10):1017-1020. doi:10.1111/j.1471-0528.2001.00252.x \n95. Lieng M, Qvigstad E, Istre O, Langebrekke A, Ballard K. \nLong-term outcomes following laparoscopic supracervical \nhysterectomy. BJOG. 2008;115(13):1605-1610. doi:10.1111/j.1471-\n0528.2008.01854.x\n96. Einarsson JI, Suzuki Y, Vellinga TT, et al. Prospective evaluation \nof quality of life in total versus supracervical laparoscopic \nhysterectomy. J Minim Invasive Gynecol. 2011;18(5):617-621. \ndoi:10.1016/j.jmig.2011.06.003","source_license":"CC0","license_restricted":false}