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01-04-2008 | Original Article

Randomized, controlled, blinded trial of Tissucol/Tisseel for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: rationale and study design of the TIMELI trial

Authors: G. Campanelli, G. Champault, M. Hidalgo Pascual, A. Hoeferlin, A. Kingsnorth, J. Rosenberg, M. Miserez

Published in: Hernia | Issue 2/2008

Abstract

Background

Complications associated with sutured mesh fixation following open groin hernia repair have prompted surgeons to evaluate methods of atraumatic fixation such as the use of human fibrin glue. Small trials with Tissucol/Tisseel fibrin glue (Baxter Healthcare, Deerfield, IL, USA) have shown promising results that warrant further investigation.

Methods

TIMELI (Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair) is an international, controlled, randomized, patient- and evaluator-blinded study that is comparing mesh fixation with Tissucol or sutures in patients with inguinal hernia. The primary endpoint evaluates the incidence of disabling complications (chronic pain and/or numbness and/or groin discomfort) at 12 months post-surgery.

Results

Patient enrolment started in February 2006 and ended on 19 April 2007, with a total of 325 patients recruited. Initial results are expected in early 2008.

Conclusions

TIMELI is a major international trial that will provide important information on the efficacy and safety of Tissucol, compared with sutures, for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair.

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Title: Randomized, controlled, blinded trial of Tissucol/Tisseel for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: rationale and study design of the TIMELI trial
Authors: G. Campanelli
G. Champault
M. Hidalgo Pascual
A. Hoeferlin
A. Kingsnorth
J. Rosenberg
M. Miserez
Publication date: 01-04-2008
Publisher: Springer-Verlag
Published in: Hernia / Issue 2/2008
Print ISSN: 1265-4906
Electronic ISSN: 1248-9204
DOI: https://doi.org/10.1007/s10029-007-0315-3

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Randomized, controlled, blinded trial of Tissucol/Tisseel for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: rationale and study design of the TIMELI trial

Abstract

Background

Methods

Results

Conclusions

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Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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