Open randomized clinical trial of laparoscopic versus open incisional hernia repair

Abstract

Background: Incisional hernia is a common complication following abdominal surgery. Although the use of prosthetics has decreased recurrence rates, the standard open approach is still unsatisfactory. Laparoscopic techniques are an attempt to provide similar outcomes with the advantages of minimally invasive surgery.

Methods: Open randomized controlled clinical trial with follow-up at 1, 2, 3, 7, and 15 days, and 1, 3, and 12 months from hernia repair. The study was carried out in the surgery departments of three general hospitals of the Valencia Health Agency.

Objectives: To compare laparoscopic with anterior open repair using health-related quality of life outcomes as main endpoints.

Results: Eighty-four patients with incisional hernia were randomly allocated to an open group (OG) (n = 39) or to a laparoscopic group (LG) (n = 45). Seventy-four patients completed 1-year follow up. Mean length of stay and time to oral intake were similar between groups. Operative time was 32 min longer in the LG (p < 0.001). Conversion rate was 11%. The local complication rate was superior in the LG (33.3% versus 5.2%) (p < 0.001). Recurrence rate at 1 year (7.9% versus 9.7%) was similar in the two groups. There were no significant differences in the pain scores or the EQ5D tariffs between the two groups during follow-up.

Conclusions: Laparoscopic incisional hernia repair does not seem to be a better procedure than the open anterior technique in terms of operative time, hospitalization, complications, pain or quality of life.