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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*,**

doi: 10.1097/SLA.0000000000000297
Original Articles

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: Identifier: NCT01637818.

Supplemental Digital Content is Available in the Text.The technique of best choice in open prosthetic inguinal hernia repair remains a subject of ongoing debate. Here we report the long-term follow-up results of our previously published randomized controlled trial comparing mesh plug repair with Lichtenstein's operation. These data do not provide enough evidence that mesh plug repair, and Lichtenstein's operation are different with respect to long-term recurrence rates.

*Division of General and Visceral Surgery and

Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland

Division of Visceral Surgery and Medicine, University Hospital Bern, Bern, Switzerland

§Division of Visceral Surgery, Cantonal Hospital Olten, Olten, Switzerland

Division of Visceral Surgery, Cantonal Hospital Lucerne, Lucerne, Switzerland

Division of Visceral Surgery, Kreiskrankenhaus Lörrach, Lörrach, Germany

**Division of General Surgery, Gesundheitszentrum Wetzikon, Wetzikon, Switzerland.

Reprints: Daniel M. Frey, MD, Department of Surgery, GZO Spital Wetzikon Spitalstrasse 66, CH-8620 Wetzikon, Switzerland. E-mail:

Disclosure: No funding was received for this study. The authors declare they have no conflict of interests.

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© 2014 by Lippincott Williams & Wilkins.