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生物补片可显著降低腹部造口闭合术的切口疝发生率
作者:小柯机器人 发布时间:2020/2/20 19:53:53

近日,加强造口闭合(ROCSS)协作组联合西米德兰研究协作组研究比较了生物补片与标准造口闭合术的长期疗效。相关论文于2020年2月8日发表在《柳叶刀》杂志上。

腹部造口闭合术是一种常见的择期手术,常伴有并发症,其中最常见和影响最大的是切口疝的形成。

为了探讨生物补片(胶原组织基质)能否安全地减少切口疝在造口闭合处的发生率,2012年11月28日至2015年11月11日,研究组在英国、丹麦和荷兰的37家医院进行了一项随机对照试验,招募了790名18岁及以上接受选择性回肠造口或结肠造口闭合术的患者,按1:1随机分配,394名接受生物补片闭合(补片组),396名接受标准缝合闭合(对照组)。

2年后,补片组临床可检的切口疝发生率为12%,显著低于对照组(20%)。在455例术后1年行CT扫描的患者中,补片组CT确定的切口疝发生率为9%,显著低于对照组(21%)。补片组2年后的症状性切口疝发生率和外科再干预率分别为16%和12%,对照组分别为19%和16%,差异无统计学意义。两组患者的伤口感染率、血肿率、生活质量、疼痛评分或严重不良事件等指标均无显著差异。

总之,采用生物补片的腹壁加固术在术后24个月,临床上可发现的切口疝发生率显著降低,安全性好,易被患者接受。

附:英文原文

Title: Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial

Author: Aneel Bhangu, Dmitri Nepogodiev, Natalie Ives, Laura Magill, James Glasbey, Colm Forde, Thue Bisgaard, Kelly Handley, Samir Mehta, Dion Morton, Thomas Pinkney, Samir Mehta, Kelly Handley, Natalie Ives, Aneel Bhangu, James Brown, Colm Forde, Kaori Futaba, James Glasbey, Kelly Handley, Natalie Ives, Sarah Khan, Laura Magill, Samir Mehta, Dion Morton, Dmitri Nepogodiev, Arvind Pallan, Abhilasha Patel, Steve Ashdown-Phillips, Tracy Roberts, Susan Jowett, Lorraine Munetsi, Thomas Pinkney, Andrew Torrance, James Brown, Kelly Handley, Nicholas Hilken, Matt Hill, Mark Hunter, Natalie Ives, Sarah Khan, Susan Leek, Helen Lilly, Laura Magill, Samir Mehta, Amruta Sawant, Alexandra Vince, Michael Walters, Willem Bemelman, Marjolein Blussé, Wernard Borstlap, Olivier RC Busch, Christianne Buskens, Charlotte Klaver, Hendrik Marsman, Oddeke van Ruler, Pieter Tanis, Emma Westerduin, Dennis Wicherts, Parthasarathi Das, Sharadah Essapen, Victoria Frost, Ana Glennon, Catherine Gray, Anwar Hussain, Lisa McNichol, Pasha Nisar, Humphrey Scott, Jonathan Trickett, Prateesh Trivedi, Daniel White, Talakalukoppa Amarnath, Rohan Ardley, Robin Gupta, Emily Hall, Kathryn Hodgkins, Harjeet Narula, Terri-Ann Sewell, John M Simms, Julie Toms, Tim White, Angela Atkinson, Dan Beral, Nicola Lancaster, Felicity Mackenzie, Tim Wilson, David Cruttenden-Wood, Jackie Gibbins, Mark Halls, Dennise Hill, Karen Hogben, Stephanie Jones, Michael J Lamparelli, Mark Lewis, Sarah Moreton, Paul Ng, Arabis Oglesby, James Orbell, Benjamin Stubbs, Krishnan Subramanian, Anjay Talwar, Simon Wilsher, Mohammed Al-Rashedy, Catherine Fensom, Muhammed Gok, Lisa Hardstaff, Kamran Malik, Mohammed Sadat, Barbara Townley, Lesley Wilkinson, Tracey Cosier, Sudhakar Mangam, Mohamed Rabie, Graham Broadley, John Canny, Simon Fallis, Nikki Green, Ahmed Hawash, Sharad Karandikar, Mehboob Mirza, Edward Rawstorne, Julie Reddan, Jonathan Richardson, Chris Thompson, Kathryn Waite, Haney Youssef, Thue Bisgaard, Lindsey De Nes, Steffen Rosenstock, Pernille Strandfelt, Mikkel Westen, Kamal Aryal, Kirosh Shankar Kshatriya, Roshan Lal, Vamsi Velchuru, Elva Wilhelmsen, Ayesha Akbar, Anthony Antoniou, Sue Clark, Pooja Datt, Jason Goh, Ian Jenkins, Robin Kennedy, Yasuko Maeda, Piero Nastro, Harriet Owen, Robin KS Phillips, Janindra Warusavitarne, Joanne Bradley-Potts

Issue&Volume: 2020/02/08

Abstract: 

Background
Closure of an abdominal stoma, a common elective operation, is associated with frequent complications; one of the commonest and impactful is incisional hernia formation. We aimed to investigate whether biological mesh (collagen tissue matrix) can safely reduce the incidence of incisional hernias at the stoma closure site.
Methods
In this randomised controlled trial (ROCSS) done in 37 hospitals across three European countries (35 UK, one Denmark, one Netherlands), patients aged 18 years or older undergoing elective ileostomy or colostomy closure were randomly assigned using a computer-based algorithm in a 1:1 ratio to either biological mesh reinforcement or closure with sutures alone (control). Training in the novel technique was standardised across hospitals. Patients and outcome assessors were masked to treatment allocation. The primary outcome measure was occurrence of clinically detectable hernia 2 years after randomisation (intention to treat). A sample size of 790 patients was required to identify a 40% reduction (25% to 15%), with 90% power (15% drop-out rate). This study is registered with ClinicalTrials.gov, NCT02238964.
Findings
Between Nov 28, 2012, and Nov 11, 2015, of 1286 screened patients, 790 were randomly assigned. 394 (50%) patients were randomly assigned to mesh closure and 396 (50%) to standard closure. In the mesh group, 373 (95%) of 394 patients successfully received mesh and in the control group, three patients received mesh. The clinically detectable hernia rate, the primary outcome, at 2 years was 12% (39 of 323) in the mesh group and 20% (64 of 327) in the control group (adjusted relative risk [RR] 0·62, 95% CI 0·43–0·90; p=0·012). In 455 patients for whom 1 year postoperative CT scans were available, there was a lower radiologically defined hernia rate in mesh versus control groups (20 [9%] of 229 vs 47 [21%] of 226, adjusted RR 0·42, 95% CI 0·26–0·69; p<0·001). There was also a reduction in symptomatic hernia (16%, 52 of 329 vs 19%, 64 of 331; adjusted relative risk 0·83, 0·60–1·16; p=0·29) and surgical reintervention (12%, 42 of 344 vs 16%, 54 of 346: adjusted relative risk 0·78, 0·54–1·13; p=0·19) at 2 years, but this result did not reach statistical significance. No significant differences were seen in wound infection rate, seroma rate, quality of life, pain scores, or serious adverse events.
Interpretation
Reinforcement of the abdominal wall with a biological mesh at the time of stoma closure reduced clinically detectable incisional hernia within 24 months of surgery and with an acceptable safety profile. The results of this study support the use of biological mesh in stoma closure site reinforcement to reduce the early formation of incisional hernias.

DOI: 10.1016/S0140-6736(19)32637-6

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32637-6/fulltext

 

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
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投稿链接:http://ees.elsevier.com/thelancet