title: Fibrin sealant for mesh fixation in laparoscopic umbilical hernia repair: 1-year results of a randomized controlled double-blinded study.
abstract: OBJECTIVE
  Fibrin sealant for mesh fixation has significant positive effects on early outcome after laparoscopic ventral hernia repair (LVHR) compared with titanium tacks. Whether fibrin sealant fixation also results in better long-term outcome is unknown.
  
  
  METHODS
  We performed a randomized controlled trial including patients with umbilical hernia defects from 1.5 to 5 cm at three Danish hernia centres. We used a 12 cm circular mesh. Participants were randomized to fibrin sealant or titanium tack fixation. Patients were seen in the outpatient clinic at 1 and 12 months follow-up.
  
  
  RESULTS
  Forty patients were included of whom 34 were available for intention to treat analysis after 1 year. There were no significant differences in pain, discomfort, fatigue, satisfaction or quality of life between the two groups at the 1-year follow-up. Five patients (26 %) in the fibrin sealant group and one (6 %) in the tack group were diagnosed with a recurrence at the 1-year follow-up (p = 0.182) (overall recurrence rate 17 %). Hernia defects in patients with recurrence were significantly larger than in those without recurrence (median 4.0 vs. 2.8 cm, p = 0.009).
  
  
  CONCLUSIONS
  Patients with larger hernia defects and fibrin sealant mesh fixation had higher recurrence rates than expected, although the study was not powered for assessment of recurrence. There was no significant difference between groups in any parameters after the 1-year follow-up. The beneficial effects of mesh fixation with fibrin sealant on early outcome warrant further studies on optimization of the surgical technique to prevent recurrence.
authors: Department of Surgery D, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark. jens.ravn.eriksen@regionh.dk
authors: J R
authors: JR
authors: Eriksen
authors: T
authors: T
authors: Bisgaard
authors: S
authors: S
authors: Assaadzadeh
authors: L N
authors: LN
authors: Jorgensen
authors: J
authors: J
authors: Rosenberg
mesh_terms: D004311:Double-Blind Method; D005221:Fatigue / Q000209:etiology; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D006554:Hernia, Umbilical / Q000473:pathology / Q000601:surgery*; D059685:Herniorrhaphy / Q000379:methods; D006801:Humans; D010149:Postoperative Pain / Q000209:etiology; D017060:Patient Satisfaction; D060489:Prosthesis Retention / Q000009:adverse effects / Q000379:methods*; D011788:Quality of Life; D012008:Recurrence; D013526:Surgical Mesh / Q000009:adverse effects; D013536:Suture Techniques / Q000009:adverse effects; D014014:Tissue Adhesives / Q000627:therapeutic use*
chemical_list: D015718:Fibrin Tissue Adhesive; D014014:Tissue Adhesives
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