P-065 synthetic mesh versus biological mesh to prevent incisional hernia after loop-ileostomy closure: a randomized feasibility trial

Aim Up to one third of patients experience incisional hernia after loop-ileostomy closure. Biological meshes have been commonly used in contaminated surgical sites instead of synthetic ones due to complication concerns, previous data on the subject does not support this practice. The aim of this study was to evaluate the safety and efficacy of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure. Materials & Methods A randomized, controlled, multi-center non-inferior feasibility trial was conducted from April 2018 – November 2021. Patients (n=102) were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene MacroTM, Medtronic) (SM) or a biological mesh (PermacolTM, Medtronic) (BM) to the retrorectus space at loop-ileostomy closure after anterior resection for rectal adenocarcinoma. The primary outcome was rate of surgical site infections (SSI) at 30-day follow-up and rate of incisional hernias at 10 months follow-up. Results In total, 102 patients were randomized, of which 97 received the intended allocation. Of patients in the SM group, 1/46 (2%) had SSI and in the BM group 2/48 (4%) had SSI (p>0.90) at 30 days follow-up. One patient from each group underwent reoperation requiring mesh removal (p>0.90). At 10 months follow-up, one patient (2%) in both groups had an incisional hernia on clinical examination (p>0.90) at 10 months follow-up. None of the patients had underwent reoperation due to mesh or wound-related complications. Conclusions Both a synthetic mesh and biological mesh were safe and effective in incisional hernia prevention after loop-ileostomy closure.