直肠癌腹会阴联合切除术后使用臀大肌翻转皮瓣或一期缝合进行会阴伤口闭合：一项随机对照多中心试验的研究方案（BIOPEX - 2研究）
Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study).
作者信息
Sharabiany Sarah, Blok Robin D, Lapid Oren, Hompes Roel, Bemelman Wilhelmus A, Alberts Victor P, Lamme Bas, Wijsman Jan H, Tuynman Jurriaan B, Aalbers Arend G J, Beets Geerard L, Fabry Hans F J, Cherepanin Ivan M, Polat Fatih, Burger Jacobus W A, Rutten Harm J T, Bosker Robert J I, Talsma Koen, Rothbarth Joost, Verhoef Cees, van de Ven Anthony W H, van der Bilt Jarmila D W, de Graaf Eelco J R, Doornebosch Pascal G, Leijtens Jeroen W A, Heemskerk Jeroen, Singh Baljit, Chaudhri Sanjay, Gerhards Michael F, Karsten Tom M, de Wilt Johannes H W, Bremers Andre J A, Vuylsteke Ronald J C L M, Heuff Gijsbert, van Geloven Anna A W, Tanis Pieter J, Musters Gijsbert D
机构信息
Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.
LEXOR, Centre for Experimental and Molecular Medicine, Oncode Institute, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
出版信息
BMC Surg. 2020 Jul 23;20(1):164. doi: 10.1186/s12893-020-00823-7.
BACKGROUND
Abdominoperineal 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.
METHODS
Patients 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.
DISCUSSION
The 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 REGISTRATION
The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.
背景
直肠癌腹会阴联合切除术（APR）与会阴伤口的高发病率相关，关于最佳闭合技术存在争议。在荷兰，会阴伤口一期闭合仍是标准治疗方法。在我们之前的随机对照试验（BIOPEX研究）中，生物网片闭合术并未改善伤口愈合情况。基于队列研究的荟萃分析表明，用血管丰富的组织填充会阴缺损可改善会阴伤口愈合。臀大肌翻转皮瓣似乎是实现这一目的的一种有前景的方法，且具有无供区瘢痕的优点。本研究的目的是调查臀大肌翻转皮瓣是否能改善直肠癌APR术后会阴伤口的一期愈合情况。
方法
计划接受APR的原发性或复发性直肠癌患者将被纳入这项多中心随机对照试验。排除标准包括全盆腔脏器切除术、S4/S5以上的骶骨切除术、括约肌间APR、盆底生物网片闭合术、胶原病和严重的全身性疾病。总共160名患者将被随机分为臀大肌翻转皮瓣组（试验组）和一期闭合组（对照组）。总随访期为12个月，结果评估者和患者将对会阴伤口闭合类型不知情。主要结局是术后30天时一期愈合的会阴伤口百分比，定义为南安普顿伤口评分低于2分。次要结局包括会阴伤口闭合时间、会阴疝发生率、并发症的数量、持续时间和性质、再次干预、生活质量和泌尿生殖功能。
讨论
预计使用臀大肌翻转皮瓣可使一期愈合的会阴伤口愈合率从65%提高到85%。鉴于已证实的有效性，预计这种相对简单的手术技术将很快得到应用。
试验注册
该试验于2019年7月2日在Clinicaltrials.gov上进行了回顾性注册，注册号为NCT04004650。
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