Abstract | OBJECTIVE: 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:
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Authors | Giampiero Campanelli, Manuel Hidalgo Pascual, Andreas Hoeferlin, Jacob Rosenberg, Gérard Champault, Andrew Kingsnorth, Marc Miserez |
Journal | Annals of surgery
(Ann Surg)
Vol. 255
Issue 4
Pg. 650-7
(Apr 2012)
ISSN: 1528-1140 [Electronic] United States |
PMID | 22395092
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Aged
- Double-Blind Method
- Fibrin Tissue Adhesive
- Follow-Up Studies
- Hernia, Inguinal
(surgery)
- Herniorrhaphy
(instrumentation, methods)
- Humans
- Hypesthesia
(epidemiology, prevention & control)
- Intraoperative Complications
(epidemiology)
- Length of Stay
(statistics & numerical data)
- Logistic Models
- Male
- Middle Aged
- Pain, Postoperative
(epidemiology, prevention & control)
- Postoperative Complications
(epidemiology, prevention & control)
- Quality of Life
- Recurrence
- Surgical Mesh
- Sutures
- Treatment Outcome
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