{"paper_id":"509bf0c9-84f1-4139-9b47-858052ba96b5","body_text":"Abstract\nThis is a protocol for a Cochrane Review (Intervention). The objectives are as follows:\nTo determine whether surgical excision or ablation is the optimum management of peritoneal endometriosis with respect to pain and secondary outcomes on fertility, recurrence and safety or harm issues.\nBackground\nDescription of the condition\nEndometriosis is defined as the presence of endometrial‐like tissue outside the uterus which induces a chronic inflammatory reaction (RCOG 2006). Endometriosis can be classified into the three types of peritoneal or superficial, ovarian and deep infiltrating endometriosis (Kennedy 2007). Peritoneal endometriosis comprises superficial lesions scattered over the peritoneal, serosal and ovarian surfaces. Deep infiltrating endometriosis forms nodules extending beneath the peritoneal surface and may involve the pouch of Douglas, uterosacral ligaments, vagina, bowel, bladder and ureters (Cornillie 1990). The gold standard test to diagnose endometriosis is the direct visualization of the lesions at laparoscopy or laparotomy. The revised American Fertility Society classification (Am Fert Soc 1997) provides a staging system based on visual findings at laparoscopy that reflects the extent of the implants on the peritoneum and ovaries.\nEndometriosis occurs in approximately 70% of women with chronic pelvic pain (ASRM Practice Committee 2008) and 17% of women with subfertility (Nisolle 1990). The public health toll of endometriosis is significant in terms of suffering, lost income, infertility, stress on families and costs (Mathias 1996). The precise mechanisms by which endometriosis causes pain are not completely understood. Pain may be due to nociceptive, inflammatory or neuropathic mechanisms and there is evidence that all three of these mechanisms are relevant to the pelvic pain associated with endometriosis (Giudice 2010). Infertility in women with endometriosis is also believed to be multifactorial, mediated by the distortion of the normal pelvic anatomy, inflammatory changes in the peritoneal fluid and endometrial lining, and impairment of the ovarian reserve (de Ziegler 2010).\nThere are medical and surgical treatment options for endometriosis (Jacobson 2009; Vercellini 2009). Medical treatments include hormonal drugs, such as the combined oral contraceptive pills, progestogens, danazol, gestrinone, and gonadotrophin releasing hormone analogues. Surgery is often required when medical options fail or cause unacceptable side effects. Surgery may also be considered for women who wish to conceive because most medical treatments are contraceptive (Cochrane 2003). After surgery for endometriosis, recurrence or worsening of pain has been observed in 40% to 50% of women within five years (Valle 2003), with a cumulative rate of endometrioma recurrence of up to 30% (Busacca 1999,; Chapron 2002). Recurrence may be caused by de novo re seeding of refluxed endometrial tissue (Busacca 2006), or by growing of microscopic implants which were not removed at the time of the primary surgery. In fact, visualization of endometriosis at laparoscopy may fail in women with subtle or atypical forms of peritoneal endometriosis (Nisolle 1990; Moen 1992) or in some women with deep infiltrating endometriosis not associated with peritoneal or ovarian lesions (Chapron 1996; Bonte 2002).\nA recent Cochrane review showed that the use of laparoscopic surgery in the treatment of minimal and mild endometriosis may improve future fertility (Cochrane 2010). However it is still unknown if women with severe endometriosis can benefit from surgical removal of endometriosis before in vitro fertilization. In such cases, the co‐existence of pain symptoms and individual preferences should be taken into account. The surgical removal of endometriosis may not reverse the biomolecular changes associated with endometriosis (de Ziegler 2010) and this may limit the effectiveness of surgical treatment.\nDescription of the intervention\nThe surgical treatment of endometriosis aims to remove all areas of peritoneal, ovarian and deep infiltrating endometriosis and to restore the pelvic anatomy by division of the adhesions. An optimal surgical treatment requires destruction of all endometriotic lesions visible at surgery. The surgical treatment of endometriosis may be divided into ablative or excisional techniques.\nHistorically the initial treatment of endometriosis involved laparotomy and surgical excision of the diseased tissue using a scalpel or scissors (Cullen 1920,; Sampson 1921). With the advent of minimally invasive surgery, diathermy, laser, helium plasma coagulation or ultrasound have all been used via the laparoscopic ports for the ablation of the endometriosis implants. 'Ablation' means physical elimination of the diseased tissue via coagulation or vaporization. Diathermy uses a monopolar or bipolar current to achieve coagulation (Hasson 1979). Laser treatment implies the vaporization of endometriosis implants with a carbon dioxide (CO2) or potassium‐titanyl‐phosphate laser (Sutton 1994). Helium plasma coagulation uses a combination of low volume helium gas and very low electrical power to coagulate the implants (Nardo 2005).\nMore recently, thanks to the improvements in laparoscopic tools and surgical techniques, the same energy sources can be used for excision of the diseased tissue rather than ablation (Redwine 1993; Wood 1996). When an excisional technique is used, the diseased peritoneum is usually grasped and displaced away from underlying structures and excised with a small portion of surrounding healthy tissue. Excised lesions can be submitted for individual biopsy confirmation.\nHow the intervention might work\nThe treatment of deep infiltrating endometriosis is usually carried out using excisional techniques (Chapron 2004). In fact, infiltrating or nodular disease is difficult to recognize by inspection only and the depth of penetration may become apparent only during the excision, with palpation of the diseased tissue. Also, in women with endometriomata there is good evidence that excision provides for more favourable outcomes in terms of pain recurrence and fertility when compared to ablation (Cochrane 2009). However the optimal surgical management of peritoneal endometriosis, whether by excision or ablation of the implants, is still controversial.\nWhen compared to excisional techniques, ablative procedures are theoretically more likely to be incomplete because of failure to recognize the depth of invasion and significant risks of thermal damage to underlying structures. Observational studies have shown that the extent of endometriosis can be underestimated with visualization. Occult microscopic endometriosis has been found in 13% to 50% of normal‐looking peritoneum next to visible implants (Nisolle 1988; Martin 1990). With excisional techniques the resection of the implants can be extended to the surrounding normal peritoneum, thus making excision potentially more complete than ablation. With ablative procedures a greater amount of necrotic tissue can be left behind, with a potentially greater inflammatory reaction and increased risk of adhesions and pain (Hubbard 1967; Ling 1989). Conversely, excisional techniques leave normal underlying connective tissue on which rapid regrowth of peritoneum is possible.\nInjuries to the ureters and major blood vessels have been reported with the use of bipolar electrosurgery and laser on the pelvic side walls (Grainger 1990; Nezhat 1996). With excisional techniques, those endometriotic implants lying over important structures are treated by opening the peritoneum away from the structure and then carefully dissecting the peritoneum away from the underlying structures to excise the lesion completely. Excision may then represent a safer approach, especially for those locations at risk of thermal damage, such as the peritoneum overlying the ureters and important vessels or the bowel. However, excision might be more complex to perform and may require longer operating times compared to ablation. Excision also carries the benefit of histological confirmation, which is of relevance considering that lesions appearing to be endometriosis at laparoscopy are proven histologically to be endometriosis in only 47% to 81% of cases (Jansen 1986).\nWhy it is important to do this review\nThe surgical treatment of ovarian endometriosis has already been the subject of a Cochrane review (Cochrane 2009). Our review will clarify which is the most effective surgical technique for treating peritoneal (or superficial) endometriosis; either excision of the peritoneal implants or ablation techniques. It will also serve to highlight any lack of evidence from randomised controlled trials in this field and potentially identify areas for further research.\nObjectives\nTo determine whether surgical excision or ablation is the optimum management of peritoneal endometriosis with respect to pain and secondary outcomes on fertility, recurrence and safety or harm issues.\nMethods\nCriteria for considering studies for this review\nTypes of studies\nOnly randomised controlled trials (RCTs) will be eligible for inclusion. Non‐RCTs and quasi‐randomised RCTs will be excluded.\nTypes of participants\nInclusion criteria\nWomen with peritoneal endometriosis who are undergoing surgery for pain or infertility\nEndometriosis is defined as direct visualization of peritoneal endometriosis implants at surgery, with or without histological confirmation\nExclusion criteria\nWomen with infiltrating or nodular disease at laparoscopy\nWomen with endometriomata\nWomen with gynaecological cancer\nWomen with peritoneal lesions other than endometriosis\nTypes of interventions\nInclusion criteria\nRCTs comparing excision and ablation of peritoneal endometriosis (both laparotomy and laparoscopy)\nExclusion criteria\nPain treatments other than excision or ablation, like laparoscopic uterine nerve ablation (LUNA) or presacral neurectomy\nTypes of outcome measures\nPrimary outcomes\nRelief from pelvic pain as measured by visual analogue scores or categorical data\nSecondary outcomes\nSubsequent fertility including pregnancy and live birth rates, either spontaneous or as result of fertility treatment\nRecurrence of endometriosis (recurrence of pain or endometriosis identified at subsequent surgery)\nSafety or harm issues (bleeding; infections; damage to ureters, bladder, bowel, major vessels; conversion to laparotomy; other adverse events)\nOperating time\nLength of hospital stay\nAnalgesia requirements (time to first rescue analgesic, need for opioid analgesics)\nQuality of life as measured by women's satisfaction or objective quality of life scales. If studies report more than one scale, preference will be given to the Endometriosis Health Profile Questionnaire (EHP‐30) (Jones 2001)\nSearch methods for identification of studies\nAll published and unpublished RCTs of excision versus ablation of endometriosis will be sought using the following search strategy, without language restriction and in consultation with the Menstrual Disorders and Subfertility Group (MDSG) Trials Search Co‐ordinator.\nElectronic searches\nThe following electronic databases, trial registers and web sites will be searched (to September 2010): the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, PsycINFO and CINAHL. The MEDLINE search will be combined with the Cochrane highly sensitive search strategy for identifying randomised trials, which appears in the searching chapter of The Cochrane Handbook for Systematic Reviews of Interventions. The EMBASE search will be combined with trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN) (http://www.sign.ac.uk/methodology/filters.html#random).\nOther electronic sources of trials will include the following.\nTrial registers for ongoing and registered trials: 'Current Controlled Trials' (www.controlled‐trials.com/), 'ClinicalTrials.gov' a service of the US National Institutes of Health (http://clinicaltrials.gov/ct2/home) and the 'World Health Organization International Trials Registry Platform search portal' (www.who.int/trialsearch/Default.aspx).\nCitation indexes (http://scientific.thomson.com/products/sci/).\nConference abstracts in the ISI Web of Knowledge (http://isiwebofknowledge.com/).\nLILACS database, as a source of trials from the Portuguese and Spanish speaking world (http://bases.bireme.br/cgibin/wxislind.exe/iah/online/?IsisScript=iah/iah.xis&base=LILACS&lang=i&form=F).\n'Clinical Study Results' for clinical trial results of marketed pharmaceuticals (www.clinicalstudyresults.org/).\nPubMed (www.ncbi.nlm.nih.gov/pubmed/); the random control filter for PubMed will be taken from the searching chapter of the Cochrane Handbook for Systematic Reviews of Interventions.\nOpenSIGLE database (http://opensigle.inist.fr/) and Google for grey literature.\nSearching other resources\nThe reference lists of articles retrieved by the search will be handsearched and personal contact will be made with experts in the field to obtain any additional relevant data. Any relevant journals and conference abstracts that are not covered in the MDSG register will be handsearched in liaison with the Trial Search Co‐ordinator.\nData collection and analysis\nData collection and analysis will be conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008).\nSelection of studies\nOne review author will scan the titles and abstracts of articles retrieved by the search and remove those that are very clearly irrelevant. The full text of all potentially eligible studies will be retrieved. Two review authors will independently examine the full text articles for compliance with the inclusion criteria and will select studies eligible for inclusion in the review. Authors will correspond with study investigators, if required, to clarify study eligibility (for example with respect to participant eligibility criteria and allocation method). Disagreements as to study eligibility will be resolved by consensus or by discussion with a third author.\nData extraction and management\nData will be extracted from eligible studies using a data extraction form designed and pilot‐tested by the authors. Where studies have multiple publications, the main trial report will be used as the reference and additional details supplemented from secondary papers. Review authors will correspond with study investigators in order to resolve any data queries, as required. Two review authors (one a methodologist and one a topic area specialist) will independently extract the data. Any disagreement between these review authors will be resolved by a third review author.\nAssessment of risk of bias in included studies\nThe included studies will be assessed for risk of bias using the Cochrane risk of bias assessment tool (see Appendix C) to assess: sequence generation; allocation concealment; blinding of participants and outcome assessors; completeness of outcome data; selective outcome reporting; and other potential sources of bias. Two authors will assess these six domains, with any disagreements resolved by consensus or by discussion with a third author. All judgments will be fully described. The conclusions will be presented in the 'Risk of bias' table and will be incorporated into the interpretation of review findings by means of sensitivity analyses if there are sufficient data.\nMeasures of treatment effect\nCategorical data will be collapsed to form dichotomous outcomes. For dichotomous data the numbers of events in the different intervention groups of each study will be used to calculate Peto odds ratios. For continuous data, mean differences between intervention groups will be calculated if all studies report exactly the same outcomes. If similar outcomes are reported on different scales, the standardised mean difference will be calculated. Ordinal data (for example quality of life scores) will be treated as continuous data. The 95% confidence intervals will be presented for all outcomes.\nUnit of analysis issues\nThe primary analysis will be per woman randomised. Reported data that do not allow valid analysis will be briefly summarised in an additional table and will not be meta‐analysed.\nDealing with missing data\nThe data will be analysed on an intention‐to‐treat basis as far as possible and attempts will be made to obtain missing data from the original investigators. Where these are unobtainable, imputation of individual values will be undertaken for the primary outcomes only. If studies report sufficient detail to calculate mean differences but have no information on associated standard deviations (SD), the outcome will be assumed to have a SD equal to the highest SD from other studies within the same analysis. For other outcomes, only the available data will be analysed. Any imputation undertaken will be subjected to sensitivity analysis (see below).\nAssessment of heterogeneity\nThe authors will consider whether the clinical and methodological characteristics of the included studies are sufficiently similar for meta‐analysis to provide a meaningful summary. Statistical heterogeneity will be assessed by the measure of the I2 statistic. An I2 statistic greater than 50% will be taken to indicate a substantial heterogeneity (Higgins 2008). If substantial heterogeneity is detected, possible explanations will be explored in sensitivity analyses if there are sufficient data.\nAssessment of reporting biases\nIn view of the difficulty in detecting and correcting for publication bias and other reporting biases, the authors will aim to minimise their potential impact by ensuring a comprehensive search for eligible studies and by being alert for duplication of data. If there are 10 or more studies in an analysis, a funnel plot will be used to explore the possibility of small study effects (a tendency for estimates of the intervention effect to be more beneficial in smaller studies). Where possible, within study reporting bias will be detected by seeking published protocols and comparing the outcomes between the protocol and the final published study.\nData synthesis\nThe data from primary studies will be combined using a fixed‐effect model in the following comparisons.\n1. Excision versus ablation (diathermy, laser, helium plasma coagulation, ultrasound).\n2. Laparoscopic surgical intervention (excision, diathermy, laser, helium plasma coagulation, ultrasound) versus open surgical intervention.\nSubgroup analysis and investigation of heterogeneity\nSubgroup analysis will be undertaken by looking at the indication for surgery (pain or infertility). Analysis of ablation techniques will be stratified according to the modality used (electrosurgery, laser, helium plasma coagulation, ultrasound).\nSensitivity analysis\nSensitivity analyses will be conducted for the primary outcomes to determine whether the conclusions are robust to arbitrary decisions made regarding the eligibility of studies and the analysis. These analyses will include consideration of whether conclusions would have differed if: 1. eligibility was restricted to studies without high risk of bias; 2. alternative imputation strategies had been adopted; 4. the summary effect measure was relative risk rather than odds ratio.\nAcknowledgements\nMDSG group\nAppendices\nAppendix 1. EMBASE\nDatabase: EMBASE 1 exp Endometriosis/ 2 adenomyosis.tw. 3 Endometrio$.tw. 4 pelvic pain.tw. 5 dyspareunia.tw. 6 dyschezia.tw. 7 or/1‐6 8 ablati$.tw. 9 electrocoagulation.tw. 10 laser$.tw. 11 (ultrasound$ or ultrasonic).tw. 12 microwave$.tw. 13 electrosurg$.tw. 14 hypertherm$.tw. 15 photodynam$.tw. 16 thermotherap$.tw. 17 phototherap$.tw. 18 cryoablat$.tw. 19 radiofreq$.tw. 20 cryosurgery.tw. 21 exp ablation therapy/ 22 exp laparoscopy/ or exp laparotomy/ 23 Laparoscop$.tw. 24 diathermy.tw. 25 laparotom$.tw. 26 excision$.tw. 27 or/8‐26 28 7 and 27 29 Clinical Trial/ 30 Randomized Controlled Trial/ 31 exp randomization/ 32 Single Blind Procedure/ 33 Double Blind Procedure/ 34 Crossover Procedure/ 35 Placebo/ 36 Randomi?ed controlled trial$.tw. 37 Rct.tw. 38 random allocation.tw. 39 randomly allocated.tw. 40 allocated randomly.tw. 41 (allocated adj2 random).tw. 42 Single blind$.tw. 43 Double blind$.tw. 44 ((treble or triple) adj blind$).tw. 45 placebo$.tw. 46 prospective study/ 47 or/29‐46 48 case study/ 49 case report.tw. 50 abstract report/ or letter/ 51 or/48‐50 52 47 not 51 53 28 and 52 54 (2009$ or 2010$).em. 55 53 and 54\nAppendix 2. MEDLINE\nDatabase: Ovid MEDLINE® In‐Process and Other Non‐Indexed Citations, Ovid MEDLINE® Daily and Ovid MEDLINE(R) 1 exp Endometriosis/ 2 adenomyosis.tw. 3 Endometrio$.tw. 4 pelvic pain.tw. 5 dyspareunia.tw. 6 dyschezia.tw. 7 or/1‐6 8 exp ablation techniques/ or exp cautery/ or exp cryosurgery/ or exp endometrial ablation techniques/ or exp high‐intensity focused ultrasound ablation/ or exp ultrasound, high‐intensity focused, transrectal/ or exp laser therapy/ or exp laser coagulation/ 9 ablati$.tw. 10 electrocoagulation.tw. 11 laser$.tw. 12 (ultrasound$ or ultrasonic).tw. 13 microwave$.tw. 14 electrosurg$.tw. 15 hypertherm$.tw. 16 photodynam$.tw. 17 thermotherap$.tw. 18 phototherap$.tw. 19 cryoablat$.tw. 20 radiofreq$.tw. 21 cryosurgery.tw. 22 excision.tw. 23 exp Laparoscopy/ 24 Laparoscop$.tw. 25 diathermy.tw. 26 exp laparotomy/ or exp surgical procedures, minimally invasive/ 27 laparotom$.tw. 28 or/8‐27 29 7 and 28 30 randomized controlled trial.pt. 31 controlled clinical trial.pt. 32 randomized.ab. 33 placebo.tw. 34 clinical trials as topic.sh. 35 randomly.ab. 36 trial.ti. 37 (crossover or cross‐over or cross over).tw. 38 or/30‐37 39 exp animals/ not humans.sh. 40 38 not 39 41 29 and 40\nAppendix 3. CENTRAL\nDatabase: EBM Reviews ‐ Cochrane Central Register of Controlled Trials, The Cochrane Library 1 exp Endometriosis/ 2 adenomyosis.tw. 3 Endometrio$.tw. 4 pelvic pain.tw. 5 dyspareunia.tw. 6 dyschezia.tw. 7 or/1‐6 8 exp ablation techniques/ or exp cautery/ or exp cryosurgery/ or exp endometrial ablation techniques/ or exp high‐intensity focused ultrasound ablation/ or exp ultrasound, high‐intensity focused, transrectal/ or exp laser therapy/ or exp laser coagulation/ 9 ablati$.tw. 10 electrocoagulation.tw. 11 laser$.tw. 12 (ultrasound$ or ultrasonic).tw. 13 microwave$.tw. 14 electrosurg$.tw. 15 hypertherm$.tw. 16 photodynam$.tw. 17 thermotherap$.tw. 18 phototherap$.tw. 19 cryoablat$.tw. 20 radiofreq$.tw. 21 cryosurgery.tw. 22 excision.tw. 23 exp Laparoscopy/ 24 Laparoscop$.tw. 25 diathermy.tw. 26 exp laparotomy/ or exp surgical procedures, minimally invasive/ 27 laparotom$.tw. 28 or/8‐27 29 7 and 28\nAppendix 4. PsycINFO\nDatabase: PsycINFO 1 exp gynecological disorders/ 2 adenomyosis.tw. 3 Endometrio$.tw. 4 pelvic pain.tw. 5 dyspareunia.tw. 6 dyschezia.tw. 7 or/1‐6 8 ablati$.tw. 9 electrocoagulation.tw. 10 laser$.tw. 11 (ultrasound$ or ultrasonic).tw. 12 microwave$.tw. 13 electrosurg$.tw. 14 hypertherm$.tw. 15 photodynam$.tw. 16 thermotherap$.tw. 17 phototherap$.tw. 18 cryoablat$.tw. 19 radiofreq$.tw. 20 cryosurgery.tw. 21 excision.tw. 22 exp surgery/ 23 Laparoscop$.tw. 24 diathermy.tw. 25 laparotom$.tw. 26 or/8‐25 27 7 and 26\nWhat's new\n| Date | Event | Description |\n|---|---|---|\n| 29 July 2019 | Amended | The protocol has been withdrawn. 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