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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.
Ann Surg 2012; 255(4):650-7AnnS

Abstract

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+Show Affiliations

Department of Surgical Sciences, University of Insubria-Varese, Multimedica Santa Maria Hospital, Castellanza, Varese, Italy. Giampiero.Campanelli@multimedica.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22395092

Citation

Campanelli, Giampiero, et al. "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." Annals of Surgery, vol. 255, no. 4, 2012, pp. 650-7.
Campanelli G, Pascual MH, Hoeferlin A, et al. 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. Ann Surg. 2012;255(4):650-7.
Campanelli, G., Pascual, M. H., Hoeferlin, A., Rosenberg, J., Champault, G., Kingsnorth, A., & Miserez, M. (2012). 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. Annals of Surgery, 255(4), pp. 650-7. doi:10.1097/SLA.0b013e31824b32bf.
Campanelli G, et al. 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. Ann Surg. 2012;255(4):650-7. PubMed PMID: 22395092.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Campanelli,Giampiero, AU - Pascual,Manuel Hidalgo, AU - Hoeferlin,Andreas, AU - Rosenberg,Jacob, AU - Champault,Gérard, AU - Kingsnorth,Andrew, AU - Miserez,Marc, PY - 2012/3/8/entrez PY - 2012/3/8/pubmed PY - 2012/7/17/medline SP - 650 EP - 7 JF - Annals of surgery JO - Ann. Surg. VL - 255 IS - 4 N2 - 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). SN - 1528-1140 UR - https://www.unboundmedicine.com/medline/citation/22395092/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_ L2 - http://Insights.ovid.com/pubmed?pmid=22395092 DB - PRIME DP - Unbound Medicine ER -