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Snapshot Study on the Value of Omentoplasty in Abdominoperineal Resection with Primary Perineal Closure for Rectal Cancer.

ABSTRACT: BACKGROUND:Perineal wound complications are often encountered following abdominoperineal resection (APR). Filling of the pelvic space by omentoplasty (OP) might prevent these complications, but there is scant evidence to support its routine application. OBJECTIVE:The aim of this study was to evaluate the impact of OP on perineal wound complications. METHODS:All patients undergoing APR with primary perineal closure (PPC) for non-locally advanced rectal cancer in 71 Dutch centers in 2011 were selected from a cross-sectional snapshot study. Outcomes were compared between PPC with or without OP, which was based on variability in practice among surgeons. RESULTS:Of 639 patients who underwent APR for rectal cancer, 477 had a non-locally advanced tumor and PPC was performed. Of those, 172 (36%) underwent OP. Patients with OP statistically more often underwent an extralevator approach (32% vs. 14%). Median follow-up was 41 months (interquartile range 22-47). There were no significant differences with or without OP in terms of non-healing of the perineal wound at 30 days (47% vs. 48%), non-healing at the end of follow-up (9% vs. 5%), pelvic abscess (12% vs. 13%) or re-intervention for ileus (5% vs. 3%). Perineal hernia developed significantly more often after OP (13% vs. 7%), also by multivariable analysis (odds ratio 2.61, 95% confidence interval 1.271-5.364; p = 0.009). CONCLUSIONS:In contrast to previous assumptions, OP after APR with PPC appeared not to improve perineal wound healing and seemed to increase the occurrence of perineal hernia. These findings question the routine use of OP for primary filling of the pelvic space.

SUBMITTER: Blok RD

PROVIDER: S-EPMC5814519 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Snapshot Study on the Value of Omentoplasty in Abdominoperineal Resection with Primary Perineal Closure for Rectal Cancer.

Blok Robin D RD Musters Gijsbert D GD Borstlap Wernard A A WAA Buskens Christianne J CJ Bemelman Wilhelmus A WA Tanis Pieter J PJ

Annals of surgical oncology 20171212 3

<h4>Background</h4>Perineal wound complications are often encountered following abdominoperineal resection (APR). Filling of the pelvic space by omentoplasty (OP) might prevent these complications, but there is scant evidence to support its routine application.<h4>Objective</h4>The aim of this study was to evaluate the impact of OP on perineal wound complications.<h4>Methods</h4>All patients undergoing APR with primary perineal closure (PPC) for non-locally advanced rectal cancer in 71 Dutch cen ...[more]

PMID: 29235007

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Project description:BackgroundPrimary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy compared to primary perineal wound closure.Methods/designIn this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs.DiscussionThe BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia.Trail registration numberNCT01927497 (Clinicaltrial.gov).

Project description:BackgroundAbdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose, and with the advantage of not having a donor site scar. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer.MethodsPatients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function.DiscussionThe uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place.Trial registrationThe trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.

Project description:IntroductionAbdominoperineal resections performed for anorectal tumours leave a large pelvic and perineal defect causing a high rate of morbidity of the perineal wound (40%-60%). Biological meshes offer possibilities for new standards of perineal wound reconstruction. Perineal fillings with biological mesh are expected to increase quality of life by reducing perineal morbidity.Methods and analysisThis is a multicentre, randomised and single-blinded study with a blinded endpoint evaluation, the experimental arm of which uses a biological mesh and the control arm of which is defined by the primary closure after abdominoperineal resection for cancer. Patients eligible for inclusion are patients with a proven history of rectal adenocarcinoma and anal canal epidermoid carcinoma for whom abdominoperineal resection was indicated after a multidisciplinary team discussion. All patients must have social security insurance or equivalent social protection. The main objective is to assess the incremental cost-utility ratio (ICUR) of two strategies of perineal closure after an abdominoperineal resection performed for anorectal cancer treatment: perineal filling with biological mesh versus primary perineal closure (70 patient in each arm). The secondary objectives focus on quality of life and morbidity data during a 1-year follow-up. Deterministic and probabilistic sensitivity analyses will be performed in order to estimate the uncertainty surrounding the ICUR. CIs will be constructed using the non-parametric bootstrap approach. A cost-effectiveness acceptability curve will be built so as to estimate the probability of efficiency of the biological meshes given a collective willingness-to-pay threshold.Ethics and disseminationThe study was approved by the Regional Ethical Review Board of 'Nord Ouest 1' (protocol reference number: 20.05.14.60714; national number: 2020-A01169-30).The results will be disseminated through conventional scientific channels.Trial registration numberClinicalTrials.gov Registry (NCT02841293).

Dataset Information

Snapshot Study on the Value of Omentoplasty in Abdominoperineal Resection with Primary Perineal Closure for Rectal Cancer.

Publications

Snapshot Study on the Value of Omentoplasty in Abdominoperineal Resection with Primary Perineal Closure for Rectal Cancer.

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