Recurrence rate and mesh bulging are reduced with primary fascial closure in ventral hernia repair: the PROSECO randomized clinical trial.

Abstract

Laparoscopic intraperitoneal onlay mesh repair using a bridging technique has shown high rates of hernia site complications. Primary fascial closure before mesh placement has been utilized to address this. This randomized, parallel, double-blind, multicentre controlled trial investigated whether primary fascial closure reduces hernia site complications. Adults undergoing laparoscopic intraperitoneal onlay mesh repair for a midline hernia were randomized to primary fascial closure or bridging. Clinical assessment and the Ventral Hernia Pain Questionnaire were completed preoperatively and at 3 and 12 months post-surgery. CT scans were performed pre- and 12 months post-surgery. It was hypothesized that non-resorbable suture closure would reduce complication rates from 30% to 13% at 12 months, requiring 180 patients for 80% power and 95% significance. One hundred and ninety-two patients were randomized (97 closure, 95 bridging), with 173 (90%) completing 1-year follow-up. At 12 months, overall hernia site complication rates showed no significant difference clinically (18% versus 20%, P = 0.85) or on CT (25% versus 28%, P = 0.50). However, recurrence and mesh bulging were significantly lower with fascial closure (4% versus 20%, P = 0.006). This group also reported significantly less pain at 12 months. Although there was no difference in the primary endpoint, fascial closure resulted in significantly lower rates of recurrence and mesh bulging, along with reduced postoperative pain. These findings suggest that primary fascial closure should be recommended alongside intraperitoneal onlay mesh repair in midline hernias. The trial was registered at the ISRCTN at the start of the trial (ISRCTN51495042).