[Inguinal hernia repair. A randomized multicentric study comparing laparoscopic and open surgical repair].

Despite being one of the commonest surgical procedures, few methodologically suitable evaluations of inguinal hernia repair have been conducted in France. Between September 1995 and November 2000 men with inguinal hernias at 7 surgical centers were randomly assigned to open or laparoscopic repair. The primary endpoint was recurrence of hernias at two years and secondary endpoints were complications and postoperative pain (Visual Analogic Score). Of 404 patients assigned to one of the two procedures, 390 were available for the analysis. Median follow-up was 2.8 years for open surgery (Shouldice 98%) and 2.3 years for laparoscopy (TAP 55%; TEP 45%). Two-year follow-up was 66%. Recurrences were more common in the laparoscopic group (15.5%) than in the open group (6%) odds ratio 2.75; 95% confidence interval 1.20-6.85. This difference was statistically significant for direct hernias exclusively. The three severe intraoperative complications were reported in the laparoscopic group. The rate of local complications at 8 and 30 postoperative days were not different between the two techniques, however 8 of 9 patients with testicular pain were in the laparoscopic group. Postoperative pain at one month was less severe in the laparoscopic than in the open group (VAS 1.41.9 and 3.12.6 respectively). The rate of patients with postoperative pain (VAS>2) at one year was not related to the open or laparoscopic technique (overall 8.5%). Mean PREoperative VAS of patients with longterm postoperative pain was higher than PREoperative VAS of patients without postoperative pain, 3.9 and 2.2 respectively. Mean operating room occupation times were 11637 min and 16965 min for open and laparoscopic surgery respectively. Subject to limitations associated with the present study follow-up, open surgery might be superior to laparoscopic surgery for inguinal hernia repair.

RCT Entities:   Population Interventions Outcomes