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Randomized, Controlled, Blinded Trial of Tisseel/Tissucol for Mesh Fixation in Patients Undergoing Lichtenstein Technique for Primary Inguinal Hernia Repair: Results of the TIMELI Trial.
MedLine Citation:
PMID:  22395092     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE:: Test the hypothesis that fibrin sealant mesh fixation can reduce the incidence of postoperative pain/numbness/groin discomfort by up to 50% compared with sutures for repair of inguinal hernias using the Lichtenstein technique. BACKGROUND:: Inguinal hernia repair is the most common procedure in general surgery, thus improvements in surgical techniques, which reduce the burden of undesirable postoperative outcomes, are of clinical importance. METHODS:: A randomized, controlled, patient- and evaluator-blinded study (Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair [TIMELI]; trial NCT00306839) was conducted among patients eligible for Lichtenstein repair of uncomplicated unilateral primary inguinal small-medium sized hernia. Patients were subject to mesh fixation with either fibrin sealant or sutures. Main outcome measures were visual analogue scale (VAS) assessments for "pain," "numbness," and "groin discomfort" on a scale of 0 = best and 100 = worst outcome. The primary endpoint was a composite that evaluated the prevalence of chronic disabling complications (VAS score >30 for pain/numbness/groin discomfort) at 12 months after surgery. RESULTS:: In total, 319 patients were randomized between January 2006 and April 2007 (159 fibrin sealant, 160 sutures). At 12 months, the prevalence of 1 or more disabling complication was significantly lower in the fibrin sealant group than in the sutures group (8.1% vs 14.8%; P = 0.0344). Less pain was reported in the fibrin sealant group than in the sutures group at 1 and 6 months (P = 0.0132; P = 0.0052), as reflected by a lower proportion of patients using analgesics in the fibrin group over the study duration (65.2% vs 79.7%; P = 0.0009). Only 3 of 316 patients (0.9%) experienced recurrence. The incidences of wound-healing complications and other adverse events were comparable between groups. CONCLUSIONS:: Fibrin sealant for mesh fixation in Lichtenstein repair of small-medium sized inguinal hernias is well tolerated and reduces the rate of pain/numbness/groin discomfort by 45% relative to sutures without increasing hernia recurrence (NCT00306839).
Authors:
Giampiero Campanelli; Manuel Hidalgo Pascual; Andreas Hoeferlin; Jacob Rosenberg; Gérard Champault; Andrew Kingsnorth; Marc Miserez
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-3-5
Journal Detail:
Title:  Annals of surgery     Volume:  -     ISSN:  1528-1140     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-7     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372354     Medline TA:  Ann Surg     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
*Department of Surgical Sciences, University of Insubria-Varese, Multimedica Santa Maria Hospital, Castellanza, Varese, Italy †Hospital Universitario 12 de Octubre, Madrid, Spain ‡Hernienpraxis-Mainz, Mainz, Germany §Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark ‖CH Jean Verdier, Bondy, France ¶Peninsula Medical School, Derriford Hospital, Plymouth, UK #Department of Abdominal Surgery, Gasthuisberg University Hospital, Leuven, Belgium.
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