Randomized clinical trial of fibrin sealant versus titanium tacks for mesh fixation in laparoscopic umbilical hernia repair

Abstract

Abstract Background The use of tacks for mesh fixation may induce pain after surgery for ventral hernia. The aim of this study was to compare postoperative pain after laparoscopic ventral hernia repair (LVHR) with conventional mesh fixation using titanium tacks versus fibrin sealant (FS). Methods This randomized clinical trial included patients with an umbilical hernia defect ranging from 1·5 to 5 cm at three Danish hernia centres. Participants were assigned randomly to FS or titanium tack fixation. The primary outcome was acute pain, defined as the mean pain score on days 0–2 after surgery, measured on a 0–100-mm visual analogue scale (VAS). Results Forty patients were included, of whom 38 were available for intention-to-treat analysis after 1 month. Patients in the FS group reported less pain than those in the tack group on days 0–2, both at rest (median 19 versus 47 mm; P = 0·025) and during activity (38 versus 60 mm; P = 0·014). The absolute difference in pain score between groups was 19 (95 per cent confidence interval 3 to 34) and 20 (4 to 35) mm at rest and during activity respectively. Patients in the FS group resumed normal daily activity earlier (after median 7 versus 18 days; P = 0·027) and reported significantly less discomfort. No recurrences were observed. Conclusion Mesh fixation with FS in LVHR was associated with less acute postoperative pain, discomfort and a shorter convalescence than tack fixation. Long-term follow-up is needed to show whether the effect of FS fixation persists in terms of chronic pain and recurrence. Registration number: NCT00842842 (http://www.clinicaltrials.gov).