Randomized Double-Blinded Prospective trial of Ultrapro versus Prolene mesh in Endoscopic Totally Extraperitoneal Hernia Repair (TULP-trial)

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I. Burgmans, C. Voorbrood, N. Schouten, G.J. Clevers, P. Davids, E.J. Verleisdonk, R. Simmermacher

Moderator(s): Willem Akkersdijk (Harderwijk, The Netherlands) & Ulrich Dietz (Würzburg, Germany)

14:00 - 14:15h at Jurriaanse Zaal

Categories: Session 3. ‘Breaking news’ about groin and umbilical hernia

Parallel session: Session 3. ‘Breaking news’ about groin and umbilical hernia

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Objective:
The aim of the current study was to compare the clinical outcomes of lightweight mesh (Ultrapro®) versus heavy weight (Prolene®) mesh following endoscopic totally extraperitoneal (TEP) hernia repair.

Background:
Lightweight meshes reduce postoperative pain and stiffness in open anterior inguinal hernia repair. The discussion about this benefit for endoscopic repair is ongoing and there remain concerns about higher recurrence rates.

Methods:
Between March 2010 and October 2012, consecutive male patients with primary reducible unilateral inguinal hernia who underwent day-case endoscopic TEP were recruited.

Data were collected by validated questionnaires at day 1, day 7, after 6 weeks, 3 months, 1 year and 2 years and clinical assessment was performed after 3 months and 1 year. Outcome parameters included the incidence of acute and chronic pain, recurrence rates, foreign body feeling and quality of life (QOL) scores.

Results:
During the study period, 950 patients were included. No differences in pain scores were detected in the first 3 months postoperatively. At one year the presence of relevant pain (NRS 4-10) was significantly higher in the lightweight mesh group (2.9%) compared to the heavy weight mesh group (0.7%) (p=0.01). At 2 years this difference was still reported (p=0.03). There were 4 (0.8%) recurrent hernias in the standard mesh group and 13 (2.7%) in the lightweight group (p=0.03). No differences in foreign body feeling or QOL scores were detected at any moment.

Conclusion:
Light weight meshes are associated with increased recurrence rates and increased pain at 1 and 2 years postoperatively. The incidence of QOL scores and foreign body feeling were equal in both groups.