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Higher Recurrence Rate After Endoscopic Totally Extraperitoneal (TEP) Inguinal Hernia Repair With Ultrapro Lightweight Mesh: 5-Year Results of a Randomized Controlled Trial (TULP-trial)

Roos, Marleen, MD*; Bakker, Wouter J., BSc*; Schouten, Nelleke, MD, PhD; Voorbrood, Charlotte, MD, PhD*; Clevers, Geert Jan, MD, PhD*; Verleisdonk, Egbert Jan, MD, PhD*; Davids, Paul, MD, PhD*; Burgmans, Josephina, MD, PhD*

doi: 10.1097/SLA.0000000000002649
Randomized Controlled Trials

Objective: The aim of this study was to determine inguinal hernia recurrence rates 5 years after endoscopic totally extraperitoneal (TEP) inguinal hernia repair when either lightweight or heavyweight mesh was used.

Background: Recurrence is an important complication of inguinal hernia surgery. Higher recurrence rates of Ultrapro lightweight meshes after TEP repair have been demonstrated, yet data regarding long-term follow-up are limited.

Methods: From 2010 to 2012, 950 male adult patients with primary unilateral hernias were randomized to TEP hernia repair with heavyweight (Prolene) or lightweight (Ultrapro) mesh. Five years postoperatively, the validated PINQ-PHONE telephone questionnaire was carried out. Participants with a positive questionnaire reply were scheduled for a clinical visit. A recurrence was defined as a clinically detectable bulge in the operated groin on physical examination.

Results: Data on development of recurrence could be obtained from 790 patients (83.2% 5-year follow–up rate). Four patients presented with a recurrence at the outpatient clinic between 2 and 5 years postoperatively. Thirty-five patients (4.6%) with a positive PINQ-PHONE reply (60.0% lightweight vs 40.0% heavyweight) were physically examined at the outpatient clinic. In 2 patients (lightweight) a recurrence was detected. The total 5-year recurrence rate after TEP hernia repair was 2.4% (3.8% lightweight, 1.1% heavyweight, P = 0.01). A significantly higher recurrence rate for lightweight mesh in primary direct hernias was found (P = 0.003).

Conclusions: The overall recurrence rate 5 years after TEP repair was low. Ultrapro lightweight meshes showed higher recurrence rates than heavyweight meshes and are not recommended for endoscopic TEP inguinal hernia repair.

*Department of Surgery/Hernia Clinic, Diakonessenhuis Zeist/ Utrecht, The Netherlands

Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.

Reprints: Marleen Roos, MD, Department of Surgery, Diakonessenhuis Utrecht/Zeist, Room, Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL Zeist, The Netherlands. E-mail: mroos@diakhuis.nl.

A research grant has been assigned to the Diakonessenhuis/Hernia Clinic Zeist by Johnson & Johnson Medical BV to partially support all research regarding the endoscopic totally extraperitoneal hernia repair.

Disclosures: M.M.R., W.J.B., C.E.H.V., G.J.C., E.J.M.M.V., P.H.P.D., and J.P.J.B. confirm that a Research Grant has been assigned to the Diakonessenhuis Utrecht/Zeist, or more specifically to the Hernia Centre Zeist, by Johnson & Johnson Medical BV. The Research Grant is intended to support all manuscripts regarding the results and complications of the Totally Extraperitoneal (TEP) endoscopic hernia repair. This study itself is not directly subject of the Research Grant. Johnson & Johnson has and will have no access to data upon which the manuscript is based. A copy of the manuscript will only be provided at acceptance of the manuscript. Johnson & Johnson has no influence on the (subject of) this study whatsoever. Objectivity of data is therefore guaranteed and there is no conflict of interest. There are no (other) commercial associations that might pose a conflict of interest in connection with the submitted article. N.S. has no conflicts of interest or financial ties to disclose.

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