P003 SUMMER TRIAL: MESH VERSUS SUTURE REPAIR IN SMALL UMBILICAL HERNIAS IN ADULTS: A STUDY PROTOCOL FOR A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, MULTICENTER CLINICAL TRIAL

Abstract

Abstract Aim A gold standard procedure for small umbilical hernia repairs is still lacking today. There is an increasing evidence that mesh could be advantageous in lowering recurrence rates. A question remains with regard to optimal anatomical positioning of the mesh. We hypothesize that the use of an onlay-mesh can reduce recurrence rates without increasing complications compared to a simple-suture repair. Material and Methods A prospective, national, multicenter, randomized, double-blind clinical trial comparing a standardized 4x4 cm onlay mesh to a conventional suture repair will be conducted. 288 patients with a primary elective umbilical hernia ≤ 2 cm from 7 participating Swedish surgical centers will be enrolled. Intraoperative randomization will take place. Trial participants and follow-up clinical surgeons will be blinded to the assigned allocation. The primary outcome assessed will be postoperative recurrence at 1 and 3 years. Secondary outcomes assessed will be postoperative complications at 30 days and pain 1 year after surgery. Results 140 participants are included since February 2020 and 95 participants are randomized. Conclusions How to best repair a small umbilical hernia continues to be debated. A small onlay-mesh may become an easy and a safe method of choice to reduce recurrence rates in small umbilical hernia defects. This trial design should allow for a good assessment of differences in recurrence rate with due to the large sample size and the adequate follow-up. Guidelines for small umbilical hernia repairs have stressed the need for reliable data to improve treatment recommendations. We can expect that this trial will have a direct implication on small umbilical hernia repair standards.