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.
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.
Campanelli
G
G
University of Insubria di Varese, Varese, Italy. Giampiero.campanelli@multimedica.it
Champault
G
G
Pascual
M Hidalgo
MH
Hoeferlin
A
A
Kingsnorth
A
A
Rosenberg
J
J
Miserez
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D006552:Hernia, Inguinal / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D012107:Research Design; D018709:Statistics, Nonparametric; D013526:Surgical Mesh; D013536:Suture Techniques; D016896:Treatment Outcome
D015718:Fibrin Tissue Adhesive