{"paper_id":"7ff973d9-8278-4120-a0ea-ff3cb1136cbb","body_text":"Gentile et al. Int J Womens Health Wellness 2019, 5:097\nVolume 5 | Issue 2\nDOI: 10.23937/2474-1353/1510097\nOpen Access\nISSN: 2474-1353\nInternational Journal of\nWomen’s Health and Wellness\n• Page 1 of 4 •\nCitation: Gentile I, Rossini R, Scioscia M, Brunelli D, Ceccaroni M, et al. (2019) Fast Track Colorectal Sur-\ngery for Deep Endometriosis: A Prospective Randomized Trial. Int J Womens Health Wellness 5:097. \ndoi.org/10.23937/2474-1353/1510097\nAccepted: May 30, 2019: Published: June 01, 2019\nCopyright: © 2019 Gentile I, et al. This is an open-access article distributed under the terms of the \nCreative Commons Attribution License, which permits unrestricted use, distribution, and reproduction \nin any medium, provided the original author and source are credited.\nGentile et al. Int J Womens Health Wellness 2019, 5:097\nFast Track Colorectal Surgery for Deep Endometriosis: A Prospective \nRandomized Trial\nIrene Gentile, MD 1*, Roberto Rossini, MD 1, Marco Scioscia, MD 2, Davide Brunelli, MD 3, Marcello \nCeccaroni, MD2 and Giacomo Ruffo, MD1\n*Corresponding author:  Dr. Irene Gentile, MD, Department of General Surgery, Sacro Cuore Don Calabria General \nHospital, Via Don Sempreboni, 5-37024, Negrar, Italy, Tel: +390-3201777414\n1Department of Surgery, Sacro Cuore Don Calabria, Italy \n2Department of Obstetrics and Gynecology, Sacro Cuore Don Calabria, Italy\n3Hospital Health Direction, Sacro Cuore Don Calabria, Italy\nAbstract\nBackground and study aims: Application of fast track \nprotocols in laparoscopic colorectal surgery has been as-\nsessed in oncological cases with contrasting results. This \nstudy was to assess the feasibility and advantages in a \ngroup of young women suffering from bowel endometriosis.\nPatients and methods: Over one year, 227 women were \nrecruited for this prospective randomized study on fast track \nprotocol for laparoscopic surgery for bowel endometriosis. \nPatients were allocated to a perioperative fast-track or \nconventional care in a 1:3 ratio and clinical outcomes and \ncosts were evaluated.\nResults: Clinical outcomes and re-admissions within thirty \ndays were homogenous between the two groups. Direct \nand indirect costs were significantly lower in the fast track \ngroup (p < 0.5).\nDiscussion: A fast track protocol for laparoscopic surgery \nfor bowel endometriosis can be applied in referral centers \nproviding a direct impact on clinical management and a \ndefinite economic advantage.\nKeywords\nBowel Endometriosis, Fast track, Cost, Colorectal resection, \nLaparoscopy\nORIGInal aRtICle\nCheck for\nupdates\ngery) [1]. Endometriosis is a benign disease that occurs \nin women of reproductive age and may affect seriously \nthe quality of life and fertility [2]. The severity of the \ndisease ranges widely between asymptomatic ovarian \ncyst to severe infiltrating endometriosis [2]. Severe en-\ndometriosis (stage IV of ASRM classification, reference \n[2] occurs in less than 10% of cases and the incidence \nof bowel endometriosis in such cases [3] is as high as \n50% with colorectal localization accounting for more \nthan 90% of cases [4]. There is a general consensus on \nthe opportunity of a multidisciplinary surgical approach \nwhen severe deep endometriosis is diagnosed in order \nto reduce the chronic pelvic pain that is associated to \nthe disease [5,6] and improve the fertility rate [7]. We \ndecided to set up a fast-track protocol study mainly \nbecause it is a homogeneous population of patients of \nyoung women that may present a quicker recover after \nsurgery than older patients with colorectal cancer.\nPatients and Methods\nThis prospective randomized study (clinical trial reg-\nistration: UMIN-000014199) was carried out at Sacro \nCuore Don Calabria General Hospital of Negrar (Italy) \nbetween January and December 2013. A prospective \nrecruitment of 227 consecutive women undergoing \nelective laparoscopic bowel resection for deep infil -\ntrating intestinal endometriosis was carried out (Figure \n1). Patients were randomly assigned to a perioperative \nfast-track (group A, n = 62) or conventional (group B, n \nIntroduction\nMany studies on fast track colorectal cancer sur-\ngery have been published in the past ten years with \ncontrasting results mainly because of different popu -\nlations and surgical approach (laparoscopic/open sur-\n\nISSN: 2474-1353\nDOI: 10.23937/2474-1353/1510097\nGentile et al. Int J Womens Health Wellness 2019, 5:097\n• Page 2 of 4 •\n= 165) care in a 1 to 3 ratio. Surgeons and anesthetists \nwere blind on the group assigned. Preoperative poly -\nethylene glycol administration for bowel preparation \nwas used only in the Group B while a low-residue diet \nin Group A, in both cases without preoperative antibi -\notic prophylaxis. Fast-track program was based also on \nprompt removal of nasogastric tube after surgery, early \npostoperative oral fluid intake, resumption of oral feed-\ning (solid/semi-liquid) within 24 hours after surgery, no \nantibiotic therapy after surgery, getting the patient out \nof bed and walking on day 1, and discharge from hospi-\ntal as soon as the bowel function was restored.\n  \n1349 Patients with\nsuspect of endometriosis\n51 Patients excluded\nfor primary laparotomic approach\n1348 Patients with endometriosis\nwho underwent laparoscopy\n1039 Patients excluded\nfor endometriosis without\nbowel involvement\n259 Patients with\nbowel endometriosis\n32 Patients excluded\nfor non-elective surgery\n227 Patients with bowel endometriosis\nelegible and randomized to a study group\n62 Allocated to fast-track care 165 Allocated to conventional care\nFigure 1: Flow diagram of the progress through the phases of this prospective randomized study.\n\nISSN: 2474-1353\nDOI: 10.23937/2474-1353/1510097\nGentile et al. Int J Womens Health Wellness 2019, 5:097\n• Page 3 of 4 •\nThe average cost of routine care for laparoscopic \ncolorectal surgery is 6,141 Euros per patient while it \nis slightly increased by ileostomy (6,716 Euros) but \ndefinitely more costly in case of complications such as \nhemorrhage or pyrexia (10,768 Euros). The application \nof a fast-track program allows a reduction of costs both \nin cases with an uneventful postoperative course and in \ncases of complications as reported in Figure 2B (p < 0.5). \nFurthermore, the hospital stay affects the average costs \nnot only directly but also on the possibility to admit \nanother patient (implementation of cost-effectiveness \nand reduction of waiting list).\nDiscussion\nSurgical treatment for Deep Infiltrating Endometri -\nResults\nThe two groups were homogeneous for age (35.2 ± \n4.4 vs. 35.6 ± 5.8 years, p > 0.5), BMI (22.1 ± 3.9 vs. 21.6 ± \n3.2 Kg/m2, p > 0.5), operation time (236 vs. 244 min, p > \n0.5), intra-operative blood loss (250 vs. 235 mL, p > 0.5), \nand need for temporary ileostomy (14.5% vs. 16.4%, p \n> 0.5). No difference was seen in time to restoration of \nbowel function and total in-hospital morbidity between \nthe groups.\nThe postoperative hospital stay was significantly \nshorter in group A (Figure 2A ) with 52% of patients dis-\ncharged on day 3 (median in group B was 7 days). No \nsignificant difference was found in re-admissions within \nthirty days (17.7% vs. 15.8%, p > 0.5).\n  \nFigure 2: The graph a) Reports the postoperative stay in the two groups. The cost analysis; b) Shows an overall reduction of \ncosts (p < 0.5) between the groups and a consistent economic advantage when the subgroups are assessed: Bowel resection \n(BR), bowel resection with temporary ileostomy (BR-I), and complicated bowel resection cases (BR-C).\n\nISSN: 2474-1353\nDOI: 10.23937/2474-1353/1510097\nGentile et al. Int J Womens Health Wellness 2019, 5:097\n• Page 4 of 4 •\n2. Giudice LC, Kao LC (2004) Endometriosis. Lancet 364: \n1789-1799.\n3. American Society for Reproductive Medicine (1997) Revised \nAmerican Society for Reproductive Medicine classification of \nendometriosis: 1996. Fertil Steril 67: 817-821.\n4. Scioscia M, Bruni F, Ceccaroni M, Steinkasserer M, \nStepniewska A, et al. (2011 ) Distribution of endometriotic \nlesions in endometriosis stage IV supports the menstrual \nreflux theory and requires specific preoperative assessment \nand therapy. Acta Obstet Gynecol Scand 90: 136-139.\n5. Stepniewska A, Pomini P, Guerriero M, Scioscia M, Ruffo \nG, et al. (2010) Colorectal endometriosis: Benefits of long-\nterm follow-up in patients who underwent laparoscopic \nsurgery. Fertil Steril 93: 2444-2446. \n6. Dubernard G, Piketty M, Rouzier R, Houry S, Bazot M, et al. \n(2006) Quality of life after laparoscopic colorectal resection \nfor endometriosis. Hum Reprod 21: 1243-1247.\n7. Stepniewska A, Pomini P, Scioscia M, Mereu L, Ruffo \nG, et al. (2010 ) Fertility and clinical outcome after bowel \nresection in infertile women with endometriosis. Reprod \nBiomed Online 20: 602-609.\n8. Ruffo G, Rossini R (2013) The outcomes of laparoscopic \nresection of bowel endometriosis. Curr Opin Obstet \nGynecol 25: 302-307.\n9. Ruffo G, Crippa S, Sartori A, Partelli S, Minelli L, et al. \n(2014) Management of rectosigmoid obstruction due to \nsevere bowel endometriosis. Updates Surg 66: 59-64.\n10. Anderson AD, McNaught CE, MacFie J, Tring I, Barker \nP, et al. (2003) Randomized clinical trial of multimodal \noptimization and standard perioperative surgical care. Br J \nSurg 90: 1497-1504. \n11. Gatt M, Anderson AD, Reddy BS, Hayward-Sampson P, \nTring IC, et al. (2005) Randomized clinical trial of multimodal \noptimization of surgical care in patients undergoing major \ncolonic resection. Br J Surg 92: 1354-1362.\n12. Khoo CK, Vickery CJ, Forsyth N, Vinall NS, Eyre-Brook \nIA (2007) A prospective randomized controlled trial of \nmultimodal perioperative management protocol in patients \nundergoing elective colorectal resection for cancer. Ann \nSurg 245: 867-872. \n13. Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, \net al. (2011) Laparoscopy in combination with fast track \nmultimodal management is the best perioperative strategy \nin patients undergoing colonic surgery: A randomized \nclinical trial (LAFA-study). Ann Surg 254: 868-875.\n14. Lee TG, Kang SB, Kim DW, Hong S, Heo SC, et al. (2011) \nComparison of early mobilization and diet rehabilitation \nprogram with conventional care after laparoscopic colon \nsurgery: A prospective randomized controlled trial. Dis \nColon Rectum 54: 21-28.\n15. Zhuang CL, Ye XZ, Zhang XD, Chen BC, Yu Z (2013) \nEnhanced recovery after surgery programs versus traditional \ncare for colorectal surgery: A meta-analysis of randomized \ncontrolled trials. Dis Colon Rectum 56: 667-678.\nosis (DIE) with bowel envolvement results in complex \nprocedure associated with postoperative complications \nsuch as anastomotic leakage, rectovaginal fistula, bleed-\ning and abdominal abscess.\nThe management of this benign disease that occurs \nin women of reproducing age, seriously affecting the \nquality of life, should be executed in dedicated centers \nand also specialized minimally invasive approach.\nSurgical mamagement is the primary treatment for \nsymptomatic bowel endometriosis [8] and long term \nclinical outcomes are satisfactory when rectosigmoid \nobstruction due to severe bowel endometriosis occurs \n[9].\nIn recent years, there also are developed early re -\nhabilitation programs in order to reduce postoperative \npain and perioperative stress to lead to enhanced re -\ncovery after surgery.\nSince Kehlet Introduced this concept in early 1990’s, \nmany studies have come out and several randomized \ntrials and meta-analyzes have shown that the use of \nfast-track protocols are useful for early recovery of pa-\ntients after colorectal resection for oncological disease. \n[10-12].\nBoth the laparoscopic approach fast track programs \nmay Enhance recovery after surgery like several cohort \nseries, meta-analyzes and prospective studies suggest \n[13-15].\nConversely literature is poor in the field of fast track \nprograms applied to the surgical treatment of endome-\ntriosis. Ours would be the first prospective randomized \nstudy unicentric reported.\nKondo, et al. recently published a retrospective \nstudy of 161 patients with deep endometriosis under-\ngoing fast track surgery reporting a shorter length of \nhospital stay and a lower readmission rate in treated \npatients.\nIn Our study we confirm that the application of a fast-\ntrack protocol for elective colorectal surgery in young \nwomen with deep infiltrating endometriosis decreases \nnot only the length of hospital stay (52% of patient in \nthe fast track group was discharged on day 3, while the \nmedian in the control group was 7 days), but also the \nhospitalization costs decrease without increasing post -\noperative morbidity. The readmission within 30 days \nwas similar in both groups, suggesting that this event is \nnot directly related to the perioperative protocol strat-\negy.\nThis study was registered at the Local Ethics Commit-\ntee and on the UMIN-Clinical Trial Registry website with \nregistration number UMIN-000014199.\nReferences\n1. Kim DW, Kang SB, Lee SY, Oh HK, In MH (2013) Early \nrehabilitation programs after laparoscopic colorectal \nsurgery: Evidence and criticism. World J Gastroenterol 19: \n8543-8551.","source_license":"CC0","license_restricted":false}