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Long-term Results of a Randomized Double-blinded Prospective Trial of a Lightweight (Ultrapro) Versus a Heavyweight Mesh (Prolene) in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair (TULP-trial)

Burgmans, Josephina P. J. MD; Voorbrood, Charlotte E. H. MD; Simmermacher, Rogier K. J. MD, PhD; Schouten, Nelleke MD, PhD; Smakman, Niels MD, PhD; Clevers, GeertJan MD, PhD; Davids, Paul H. P. MD, PhD; Verleisdonk, EgbertJan M. M. MD, PhD; Hamaker, Marije E. MD, PhD; Lange, Johan F. MD, PhD; van Dalen, Thijs MD, PhD

doi: 10.1097/SLA.0000000000001579
RANDOMIZED CONTROLLED TRIALS

Objective: The aim of the randomized clinical trial was to compare the 2 years of clinical outcomes of a lightweight (Ultrapro) vs a heavyweight (Prolene) mesh for laparoscopic total extraperitoneal (TEP) inguinal hernia repair.

Background: Lightweight meshes reduce postoperative pain and stiffness in open anterior inguinal hernia repair. The discussion about a similar benefit for laparoscopic repair is ongoing, but concerns exist about higher recurrence rates.

Methods: Between March 2010 and October 2012, male patients who presented with a primary, reducible unilateral inguinal hernia who underwent day-case TEP repair were eligible. Outcome parameters included chronic pain, recurrence, foreign body feeling, and quality of life scores.

Results: During the study period, 950 patients were included. One year postoperatively the presence of relevant pain (Numeric Rating Score 4–10) was significantly higher in the lightweight mesh group (2.9%) compared with the heavyweight mesh group (0.7%) (P = 0.01), and after 2 years this difference remained significant (P = 0.03). There were 4 (0.8%) recurrent hernias in the heavyweight mesh group and 13 (2.7%) in the lightweight group (P = 0.03). No differences in foreign body feeling or quality of life scores were detected.

Conclusions: In TEP hernia surgery, there was no benefit of lightweight over heavyweight meshes observed 2 years postoperatively.

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

Department of Surgery, UMCU Utrecht, Utrecht, The Netherlands

Department of Surgery, Heerlen, The Netherlands

§Department of Geriatric Medicine, Diakonessenhuis Utrecht/Zeist, Utrecht, The Netherlands

Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.

Reprints: Josephina P. J. Burgmans, MD, Department of Surgery; Diakonessenhuis Utrecht/Zeist, Room: Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL Zeist, The Netherlands. E-mail: iburgmans@diakhuis.nl.

Disclosure: JPJB, CEHV, NS, GJC, PHPD, EJMMV, and TvD confirm that a Research Grant has been assigned to the Diakonnessenhuis Utrecht/Zeist, or more specifically to the Hernia Centre Zeist, by Johnson & Johnson. The Research Grant is intended to support all manuscripts regarding the results and complications of the TEP 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. NS, MEH, and RKJS and JFL have no conflicts of interest or financial ties to disclose.

The TULP study is registered in the Dutch Trial Register (NTR2131).

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.annalsofsurgery.com).

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