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

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.

Prevention of incisional hernia at the site of stoma closure with different reinforcing mesh types: a systematic review and meta-analysis

“…After exclusion of 23 articles, 7 studies were included in the meta-analysis [ 20 – 26 ]. In accordance with the inclusion criteria, one study was a RCT [ 22 ], while the remaining were retrospective studies [ 20 , 21 , 23 – 26 ]. Moreover, while five studies [ 20 , 23 – 26 ] involved patients undergoing ileostomies, two studies [ 21 , 22 ] enrolled both ileostomies and colostomies.…”

“…Furthermore, three studies used a biologic mesh [ 20 , 22 , 26 ], three studies used a polypropylene mesh [ 21 , 23 , 25 ] and one study used a biosynthetic mesh [ 24 ]. The mesh placement was retromuscular in two studies [ 20 , 21 ], onlay in four studies [ 23 – 26 ] and intrabdominal in the remaining one [ 22 ].…”

“…We found 4 studies [ 21 , 22 , 24 , 26 ] involving 1266 patients, reporting operative time differences between mesh and no mesh groups. A longer operative time was reported in the mesh group when compared with no mesh group, (SMD 0.941, 95% CI 0.462–1.421, p < 0.001).…”

“…Four studies [ 20 – 22 , 24 ] reported the rate of anastomotic leak in the two groups on a total of 1327 subjects. There was no significant difference in terms of risk of anastomotic leak development between mesh and no mesh groups (3.7% vs 2.7%, OR 1.598, 95% CI 0.846–3.019, p = 0.149).…”

Potential research participants’ use of information during the consent process: A qualitative pilot study of patients enrolled in a clinical trial

“…Sampling of study participants was constrained by the need to identify an ongoing clinical trial being conducted by researchers who were: willing to allow us to embed our study into their trial, including seeking an amendment to their research ethics approval, and speak to their participants; recruiting participants at a sufficient rate for us to gather our data within the 6-month study period; recruiting participants in such a way that it would not be unduly burdensome to recruit them to a further study shortly afterwards. The Reinforcement of Closure of Stoma Site (ROCSS) trial [21] met these criteria. Patients undergoing stoma reversal surgery and who agreed to participant in ROCSS were randomised either to receive a biological mesh to strengthen the stoma site or to receive the standard available therapy (i.e.…”