Primary Fascial Closure in Laparoscopic Ventral Hernia Repair. The Proseco-Trial a Randomised Double-Blinded Multicentre Trial

Background and Objective Laparoscopic ventral hernia repair was introduced in the 1990s as a bridging repair where the mesh overlaps the hernia aperture with no attempt at closure. In recent years, interest in closing the defect has grown, and several fascial defect closure methods have been reported. Trials evaluating the effectiveness of fascial closure, however, have failed to come to a conclusion. This was a double-blinded randomised controlled multicentre trial to see if fascial closure prior to mesh placement decreases hernia site complication rate. Methods Adults with a midline hernia aperture measuring 2–8 cm were randomised to either primary fascial closure prior to mesh placement or the classic bridging procedure. Clinical assessment and Ventral Hernia Pain Questionnaires (VHPQ) were answered at three and twelve months after surgery. CT scan was performed after 12 months. To reach a power of 80% and 95% significance level, 180 patients were required in this randomised study. Results A total of 192 patients were operated: 97 with primary fascial closure (PFC) and 95 with the classic technique. Of the 192 patients, 79% had completed the one-year follow-up and 92% the three-month follow-up. No differences in hernia site complications between groups were seen at three (p = 0.38) and twelve months (p = 0.73). Discussion Primary fascial closure does not reduce hernia site complications after laparoscopic ventral hernia repair at twelve months. There is a significantly increased risk of recurrence and psuedohernia at twelve months if the defect is not closed.