Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study)

BMC Surgery

Study Protocol

Marcel GW Dijkgraaf¹  Willem A Bemelman²  Gijsbert D Musters²  Pieter J Tanis²  Harm JT Rutten³  Robbert JI Bosker⁴  Jacobus WA Burger⁵  Anthony van de Ven⁶  Peter van Duijvendijk⁷  Eelco JR de Graaf⁸  Ronald JCLM Vuylsteke⁹  Baljit Singh^1,10  Christiaan Hoff^1,11  Johannes HW de wilt^1,12  Niels de Korte^1,13  Jeroen WA Leijtens^1,14  Anna AW van Geloven^1,15  Boudewijn van Etten^1,16 

[1] Clinical Research Unit, Academic Medical Centre, University of Amsterdam, Post box 22660, 1105AZ, Amsterdam, The Netherlands;Department of Surgery, Academic Medical Centre, University of Amsterdam, Post box 22660, 1105AZ, Amsterdam, The Netherlands;Department of Surgery, Catherina hospital, Eindhoven, EJ and Maastricht University Medical Centre, Michelangelolaan 2, P. Debyelaan 25 6229, 5623, Maastricht, HX, The Netherlands;Department of Surgery, Deventer Hospital, Post Box 5001, 7400CC, Deventer, The Netherlands;Department of Surgery, Erasmus Medical Centre / Daniel den Hoed, Post box 2040 3000, Rotterdam, CA, The Netherlands;Department of Surgery, Flevohospital, Hospitaalweg 1, 1315, Almere, RA, The Netherlands;Department of Surgery, Gelre Hospital, Albert Schweitzerlaan 31, 7334, Apeldoorn, DZ, The Netherlands;Department of Surgery, IJsselland hospital, Post box 690, 2900, Capelle aan de Ijssel, AR, The Netherlands;Department of Surgery, Kennemer Gasthuis, Boerhaavelaan 22, 2035, Haarlem, RC, The Netherlands;Department of Surgery, Leicester Hospital, Gwendolen Rd, Leicester, UK;Department of Surgery, Medical Centre Leeuwarden, Henri Dunantweg 2, 8934, Leeuwarden, AD, The Netherlands;Department of Surgery, Radboud University Medical Centre, Geert Grooteplein-Zuid 22, 6525, Nijmegen, GA, The Netherlands;Department of Surgery, Spaarne Hospital, Spaarnepoort 1, 2134, Spaarne, TM, The Netherlands;Department of Surgery, St. Laurentius Hospital, Monseigneur Driessenstraat 6, 6043, Roermond, CV, The Netherlands;Department of Surgery, Tergooi Hospital, Post box 10016, 1201, Hilversum, DA, The Netherlands;Department of Surgery, University Medical Centre Groningen, University of Groningen, Hanzeplein 1, 9700, Groningen, RB, The Netherlands;

关键词: Abdominoperineal resection;    Rectal cancer;    Radiotherapy;    Primary perineal wound closure;    Biological mesh;    perineal wound infection;    Perineal wound healing;   

DOI  :  10.1186/1471-2482-14-58

 received in 2014-02-09, accepted in 2014-08-21,  发布年份 2014

来源: Springer

【 摘 要 】

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).

【 授权许可】

Unknown   
© Musters et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.