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Annals of Surgery:
doi: 10.1097/SLA.0000000000000297
Original Articles

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

Droeser, Raoul A. MD*; Dell-Kuster, Salome MD, MSc*,†; Kurmann, Anita MD‡,¶; Rosenthal, Rachel MD, MSc*; Zuber, Markus MD§; Metzger, Jürg MD; Oertli, Daniel MD*; Hamel, Christian T. MD; Frey, Daniel M. MD*,**

Supplemental Author Material
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Abstract

Objective: To compare long-term results of Lichtenstein's 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 Lichtenstein's 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 plug: 21/268 hernias = 7.8%; Lichtenstein: 21/260 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) (OR: 0.58; 95% CI: 0.31, 1.09; P = 0.088) and sensory testing (17% vs 20% of patients; OR: 0.53; 95% CI: 0.21, 1.37; P = 0.190) between the 2 groups. There were less reoperations in the mesh plug than in the Lichtenstein's operation group (OR: 0.43; 95% CI: 0.22, 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 Lichtenstein's 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 Identifier: NCT01637818.

© 2014 by Lippincott Williams & Wilkins.

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