Prophylactic Bioresorbable Onlay Mesh for Incisional Hernia Prevention in Midline Surgery – Preliminary Results

Background Prophylactic mesh implantation during elective midline laparotomies has to be considered in patients at high risk of developing an incisional hernia. The implantation of a permanent synthetic mesh has been proven based on randomized controlled trials. The effectiveness of bioresorbable meshes with prevention mesh-associated complications in the long term has still to be confirmed. Method The design of this a prospective, single-arm, multicenter, across Austria (PROMIS-study) using a bioresorbable prophylactic mesh of poly-4-hydroxybutyrate in onlay position in patients at risk undergoing elective and emergency gastrointestinal surgery by midline incision. The primary endpoint of the study is to detect Surgical Site Infection (SSI) up to the 3-month and incisional hernia in 3 years follow-up. Results Up to now 30 patients were included. 73.3% (22/30) underwent colorectal surgery due to carcinoma. The incision length was median 18,5 cm and the size of the applied mesh was median 23 × 8 cm. No perioperative complications were seen. In the 3 months follow up in 3 patients SSI and in 2 patients seroma formation were detected. In the 12-month follow up of 15 pat. (50.0%) no further complications or incisional hernia were seen. Conclusions The results of this interim analysis of the PROMIS study obtained a low rate of SSI and seroma formation without an occurrence of an incisional hernia. Compared to the recent systematic review of prophylactic mesh the results of the interim analysis of the PROMIS study can be rated as promising.