Background: Laparoscopic repair of ventral incisional hernias has not been proved to be safer than open mesh repair.
Design: Prospective randomized trial conducted between February 1, 2004, to January 31, 2007.
Setting: Four Veterans Affairs medical centers.
Participants: One hundred sixty-two patients with ventral incisional hernias.
Interventions: Standardized laparoscopic or open repair.
Main outcome measures: Overall complication rates at 8 weeks and the odds of complications, adjusted for study site, body mass index, and hernia type.
Results: Of the 162 randomized patients, 146 underwent surgery (73 open and 73 laparoscopic repairs). Complications were less common in the laparoscopic group (23 patients [31.5%]) compared with the open repair group (35 patients [47.9%]; adjusted odds ratio [AOR], 0.45; 95% confidence interval [CI], 0.22-0.91; P = .03). Surgical site infection through 8 weeks was less common in the laparoscopic group (5.6% vs 23.3%; AOR, 0.2; 95% CI, 0.1-0.6). The mean worst pain score in the laparoscopic group was 15.2 mm lower on a visual analog scale at 52 weeks (95% CI, 1.0-29.3; P = .04). Time to resume work activities was shorter for the laparoscopic group than for the open repair group (median, 23.0 days vs 28.5 days), with an adjusted hazard ratio of 0.54 (95% CI, 0.28-1.04; P = .06). Overall recurrence at 2 years was 12.5% in the laparoscopic group and 8.2% in the open repair group (AOR, 1.6; 95% CI, 0.5-4.7; adjusted P = .44).
Conclusions: Laparoscopic repair was associated with fewer, albeit more severe, complications and improved some patient-centered outcomes. Trial Registration clinicaltrials.gov Identifier: NCT00240188.