title: Post-operative benefits of Tisseel(®)/Tissucol (®) for mesh fixation in patients undergoing Lichtenstein inguinal hernia repair: secondary results from the TIMELI trial.
abstract: OBJECTIVE
  The Tisseel/Tissucol for mesh fixation in Lichtenstein hernia repair (TIMELI) study showed that mesh fixation with human fibrin sealant during inguinal hernia repair significantly reduced moderate-severe complications of pain 12 months post-operatively compared with sutures. Further analyses may assist surgeons by investigating predictors of post-surgical complications and identifying patients that may benefit from Tisseel/Tissucol intervention.
  
  
  METHODS
  Univariate and multivariate analyses identified risk factors for combined pain, numbness and groin discomfort (PND) visual analogue scale (VAS) score 12 months post-operatively. Variables tested were: fixation method, age, employment status, physical activity, nerve handling, PND VAS score at pre-operative visit and 1 week post-operatively. The effect of fixation technique on separate PND outcomes 12 months post-surgery was also assessed. Analyses included the intention-to-treat (ITT) population and a subpopulation with pre-operative PND VAS > 30 mm.
  
  
  RESULTS
  316 patients were included in the ITT, with 130 patients in the subpopulation with pre-operative PND VAS > 30. Multivariate analysis identified mesh fixation with sutures, worsening pre-operative PND and worsening PND 1 week post-surgery as significant predictors of 12-month PND in the ITT population; mesh fixation with sutures was a significant predictor of 12-month PND in the pre-operative PND VAS > 30 subpopulation (p < 0.05). Mesh fixation with Tisseel/Tissucol resulted in significantly less numbness and a lower intensity of groin discomfort compared with sutures at 12 months; there was no difference in pain between the treatment groups.
  
  
  CONCLUSIONS
  Pre-operative discomfort may be an important predictor of post-operative pain, numbness and discomfort. Tisseel/Tissucol may improve long-term morbidity over conventional sutures in these patients.
authors.affiliation: Department of Surgical Science, Istituto Clinico Sant'Ambrogio, University of Insubria, Milan, Italy, giampiero.campanelli@grupposandonato.it.
authors.forename: G
authors.initials: G
authors.lastname: Campanelli
authors.forename: M H
authors.initials: MH
authors.lastname: Pascual
authors.forename: A
authors.initials: A
authors.lastname: Hoeferlin
authors.forename: J
authors.initials: J
authors.lastname: Rosenberg
authors.forename: G
authors.initials: G
authors.lastname: Champault
authors.forename: A
authors.initials: A
authors.lastname: Kingsnorth
authors.forename: M
authors.initials: M
authors.lastname: Bagot d'Arc
authors.forename: M
authors.initials: M
authors.lastname: Miserez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D006552:Hernia, Inguinal / Q000601:surgery*; D059685:Herniorrhaphy / Q000379:methods*; D006801:Humans; D006987:Hypesthesia / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology / Q000517:prevention & control*; D011184:Postoperative Period; D012307:Risk Factors; D013526:Surgical Mesh; D013537:Sutures / Q000009:adverse effects; D055815:Young Adult
chemical_list: D015718:Fibrin Tissue Adhesive