Randomized double-blinded prospective trial of fibrin sealant spray versus mechanical stapling in laparoscopic total extraperitoneal hernioplasty

Ann Surg. 2014 Mar;259(3):432-7. doi: 10.1097/SLA.0b013e3182a6c513.

Abstract

Objective: The aim of the current study was to compare the clinical outcomes of mesh fixation with fibrin sealant (FS) spray or mechanical stapling (MS) in laparoscopic total extraperitoneal hernioplasty (TEP).

Background: The most appropriate method of mesh fixation is uncertain.

Methods: Between June 2007 and June 2011, consecutive patients with primary reducible unilateral inguinal hernia who underwent day-case laparoscopic TEP were recruited. Outcome parameters included the incidence of acute and chronic pain, recurrence rates, morbidity rates, analgesic requirements, quality-of-life (QOL) scores, and direct cost.

Results: During the study period, 130 patients were included in the study. Patients in the MS group had significantly worse pain scores on the day after operation (P = 0.006). Analgesic requirements were similar between the 2 groups (P = 0.558). At 6 months, no significant differences in the incidence of chronic pain were observed (at rest, after coughing or cycling). The incidence of seroma formation was similar between the 2 groups (P = 0.64), and no recurrences were observed at 1 year. No differences in the QOL scores were detected. The direct cost of the entire hospitalization in the FS group was less expensive (P < 0.001).

Conclusions: FS and MS are both effective methods of providing mesh fixation. FS was associated with reduced acute pain but not chronic pain. The rates of seroma formation were similar. However, the use of FS for mesh fixation was less expensive. [corrected].

Trial registration: ClinicalTrials.gov NCT01727050.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Double-Blind Method
  • Female
  • Fibrin Tissue Adhesive / administration & dosage*
  • Follow-Up Studies
  • Hernia, Inguinal / surgery
  • Herniorrhaphy / methods*
  • Hong Kong / epidemiology
  • Humans
  • Incidence
  • Laparoscopy / methods*
  • Male
  • Middle Aged
  • Postoperative Complications / epidemiology
  • Postoperative Complications / prevention & control
  • Prospective Studies
  • Surgical Mesh*
  • Surgical Stapling / instrumentation*
  • Sutures*
  • Tissue Adhesives / administration & dosage
  • Treatment Outcome

Substances

  • Fibrin Tissue Adhesive
  • Tissue Adhesives

Associated data

  • ClinicalTrials.gov/NCT01727050