Prophylactic biological mesh reinforcement vs standard closure of stoma site (ROCSS): A multicentre, randomised controlled trial
The Lancet Feb 21, 2020
Experts conducted a multicentre, randomized controlled trial to examine whether biological mesh (collagen tissue matrix) can safely reduce the incidence of incisional hernias at the stoma closure site. This randomized controlled trial (ROCSS) performed in 37 hospitals across three European countries (35 UK, one Denmark, one Netherlands), individuals aged 18 years or older undergoing elective ileostomy or colostomy closure were randomly allocated applying a computer-based algorithm in a 1:1 ratio to either biological mesh reinforcement or closure with sutures alone (control). The primary endpoint measure was the appearance of clinically detectable hernia 2 years after randomization (intention to treat). Out of 1,286 screened patients, 790 were randomly assigned between Nov 28, 2012, and Nov 11, 2015. The outcomes of this study showed that reinforcement of the abdominal wall with a biological mesh at the time of stoma closure decreased clinically detectable incisional hernia within 24 months of surgery and with an acceptable safety profile. The outcomes of this research support the application of biological mesh in stoma closure site reinforcement to decrease the early formation of incisional hernias.
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