Long-term Follow-up of a Randomized Controlled Trial of Lichtensteinʼs Operation Versus Mesh Plug Repair for Inguinal Hernia

OBJECTIVE:To compare long-term results of Lichtensteinʼs operation versus mesh plug repair for open inguinal hernia repair. BACKGROUND:The technique of best choice in open prosthetic inguinal hernia repair remains a subject of ongoing debate. METHODS:In this prospective, randomized controlled multicenter trial, patients with primary or recurrent inguinal hernias were randomized to undergo either Lichtensteinʼs operation or mesh plug repair. The primary endpoint was the long-term recurrence rate. Secondary endpoints included chronic pain, sensibility disorders, and reoperation rate. RESULTS:In total, 697 hernias in 594 patients were randomized (297 patients per group). At a median follow-up of 6.5 years, 528 (76%) operated hernias in 444 (75%) patients were clinically evaluated. The recurrence rate was similar in both groups [mesh plug21/268 hernias = 7.8%; Lichtenstein21/260 hernias = 8.1%; adjusted odds ratio (OR)0.92; 95% confidence interval (CI)0.51, 1.68; P = 0.795]. We did not find a significant difference for chronic pain (Visual Analog Scale score >3) (OR0.58; 95% CI0.31, 1.09; P = 0.088) and sensory testing (17% vs 20% of patients; OR0.53; 95% CI0.21, 1.37; P = 0.190) between the 2 groups. There were less reoperations in the mesh plug than in the Lichtensteinʼs operation group (OR0.43; 95% CI0.22, 0.85; P = 0.016). CONCLUSIONS:The long-term results of this trial indicate not enough evidence for differences in recurrence, chronic pain, and sensibility disorders between mesh plug repair and Lichtensteinʼs operation but a lower likelihood for reoperation for mesh plug repair. Estimates for all endpoints were statistically not significant or based on large CIs. CLINICAL TRIALS REGISTRATION:ClinicalTrials.gov IdentifierNCT01637818.