Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial
Authors: 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, Peter Charleston, Hamish Clouston, Sarah Duff, Taher Fatayer, Anna Gipson, Nick Heywood, Muneer Junejo, James Kennedy, Helen Lalor, Chris Manning, Richard McCormick, Kathryn Parmar, Stephen Preston, Aswatha Ramesh, Abhiram Sharma, Karen Telford, Abidemi Adeosun, Toby Hammond, Susan Smolen, Joanne Topliffe, James G Docherty, Michael Lim, Michael Lim, Kathleen Macleod, Eimar Monaghan, Lesley Patience, Ian Thomas, Kenneth G Walker, Michael Walker, Angus JM Watson, Amanda Burgess, Yasser Ghanem, Georgina Glister, Sandeep Kapur, Abhilash Paily, Atanu Pal, Rathinam Ravikumar, Melissa Rosbergen, Kevin Sargen, Christopher Speakman, Anil K Agarwal, Amlan Banerjee, David Borowski, Dharmendra Garg, Talvinder Gill, Tracey Johnston, Susan Kelsey, Phanibhushana Chakravarthy Munipalle, Mohamed Tabaqchali, Deborah Wilson, Austin Acheson, Heather Cripps, Ahmed El-Sharkawy, Oliver Ng, Parveen Sharma, Kym Ward, Dawne Chandler, Edward Courtney, John Bunni, Katrina Butcher, Stephen Dalton, Ian Flindall, Joyce Katebe, Pratik Roy, Jeremy Tate, Tracy Vincent, Michael ER Williamson, James Wood, Mark Bignell, Graham Branagan, Jack Broardhurst, Helen Chave, Hilary Dean, Nigel D'Souza, Gemma Foster, Simon Sleight, Rupesh Sutaria, Ishmail Ahmed, Misra Rai Budhoo, Julie Colley, Neil Cruickshank, Kathryn Gill, Anne Hayes, Howard Joy, Carrington Kamabjha, James Plowright, Simon Radley, Mr Rea, Vijay Thumbe, Andrew Torrance, Philip Varghese, Richard Wilkin, Elzbieta Zulueta, Lynne Allsop, Bence Atkari, Krishnamurthy Badrinath, Prita Daliya, Mukul Dube, Cheryl Heeley, Richard Hind, Dominic Nash, Andrea Palfreman, Oliver Peacock, Nicholas Watson, Michelle Blodwell, Ali Javaid, Ashiq Mohamad, Karim Muhammad, Nafees Qureshi, Stephanie Ridgway, Kamran Siddiqui, Mamoon Solkar, Joanne Vere, Alexander Wordie, Jessica Chang, Sanaa Elgaddal, Marie Green, Marianne Hollyman, Nazzia Mirza, Jayne Rankin, Graham Williams, Wadah Ali, Anne Hardwick, Zakir Mohamed, Ahmad Navid, Kimberley Netherton, Mugurel Obreja, Milind Rao, Joanna Stringer, Athula Tennakoon, Timothy Bullen, Mansoor Butt, Robin Dawson, Sarah Dawson, Martin Farmer, Veerabhadram Garimella, Zoe Gates, Lisa Wilkings, Neil Yeomans, Olufunso Adedeji, Rashid Alalawi, Aamed Al Araimi, Shazad Ashraf, Simon Bach, Andrew Beggs, Carmen Cagigas, Mit Dattani, Nikolletta Dimitriou, Kaori Futaba, Manijeh Ghods-Ghorbani, James Glasbey, David Gourevitch, Geoffrey Haydon, Tariq Ismail, Christopher Keh, Dion G Morton, Mandip Narewal, Dmitri Nepogodiev, Trifonas Papettas, Tom Pinkney, Aaron Poh, Edward Ranstorne, Timothy J Royle, Tahir Shah, Jagdeep Singh, Chris Smart, Nigel Suggett, Muhammad Tayyab, Deepak Vijayan, Ravinder Vohra, Naseem Wairaich, Denise Yeung, Richard Bamford, Joanne Chambers, David Cotton, Rebecca Houlihan, James Kynaston, Rob Longman, Amelia Lowe, David Messenger, Anwar Owais, Catherine Phillpott, Jamshed Shabbir, Phil Baragwanath, Charlotte El-Sayed, Anne Gaunt, Chetan Khatri, Peter McCullough, Abhilasha Patel, Stephen Ward, Richard Wilkin, Ross Obukofe, Robert Stroud, David Mason, Nigel Williams, Ling S Wong, Sanjay Chaudhri, Jill Cooke, Melissa Cunha, Howard Fairey, Michael Norwood, Baljit Singh, Sarah Thomasset, Sian Abbott, Sarah Addison, James Archer, Aneel Bhangu, Robert Church, Erika Holford, Fionnaula Lenehan, Steve Odogwu, Lisa Richardson, Jane Sidebotham, Elaine Swan, Alison Tilley, Lynda Wagstaff, Isobel Amey, Yolanda Baird, Neil Cripps, Susanna Greenslade, Guy Harris, Bruce Levy, Paul Mckenzie, Alison Misselbrook, Sally Moore, Angela Skull, Deborah Nicol, Bala Reddy, Jessica Thrush, Miriam Iglesias Vecchio, Yvonne Dunn, Claire Williams, Sanjay Furtado, Michael Gill, Lydia Gilmore, Paul Goldsmith, Cezary Kocialkowski, Sadasivam Loganathan, Rabindra Nath, Marius Paraoan, Tracey Taylor, Andrew Allison, Joanna Allison, Nathan Curtis, Richard Dalton, Conrad D'Costa, Godwin Dennison, Jake Foster, Nader Francis, James Gibbons, Mohammed Hamdan, Alison Lewis, Jonathan Ockrim, Rishabha Sharma, Katie Spurdle, Saseendran Varadharajan, Assad Aghahoseini, David J Alexander, Dibyendu Bandyopadhyay, Ian Bradford, Praminthra Chitsabesan, Zoe Coleman, Andrew Gibson, Kostas Lasithiotakis, Dimitrios Panagiotou, Konstantinos Polyzois, Stevan Stojkovic, Nicholas Woodcock, Monica Wright, Rachel Hargest, Richard Jackson, Arumugam Rajesh, Olagunju Ogunbiyi, Andrew Slater, Ly-Mee Yu
Journal: The Lancet (2020)

<h2>Summary</h2><h3>Background</h3> 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. <h3>Methods</h3> 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. <h3>Findings</h3> 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 <i>vs</i> 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 <i>vs</i> 19%, 64 of 331; adjusted relative risk 0·83, 0·60–1·16; p=0·29) and surgical reintervention (12%, 42 of 344 <i>vs</i> 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. <h3>Interpretation</h3> 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. <h3>Funding</h3> National Institute for Health Research Research for Patient Benefit and Allergan.