Penetrating fixation device versus fibrin sealant for mesh fixation in laparoscopic repair of ventral hernia: a randomized controlled trial.

Abstract

<h4>Purpose</h4>Post-operative pain following intra peritoneal onlay mesh (IPOM) repair of ventral hernia is commonly attributed to mechanical fixation devices. Fibrin sealant is a novel technique of mesh fixation purported to cause less pain. The aim of this study was to compare postoperative pain in these two methods of mesh fixation.<h4>Methods</h4>This was a double-blinded, randomized controlled trial. Eighty patients with primary ventral hernia underwent laparoscopic IPOM repair using PROCEED™ mesh, which was fixed with either mechanical fixation device, SECURESTRAP™ (MF group) or fibrin sealant, TISSEEL™ (FS group). Primary end point was postoperative pain at rest and movement on a Visual Analogue Scale (VAS) of 0-10. Operative time, recurrence, seroma and quality of life (QoL) were secondary outcomes. Patients were followed up for one year.<h4>Results</h4>There was no significant difference in pain score at 12 h, 24 h, 7 days, 1, 3 and 12 months between the groups, except pain on movement, which was significantly less in the FS group on the seventh day (median VAS 3 vs. 2, p = 0.01). Mean operative time was 8 min longer in the FS group (p = 0.001). Two patients in the FS and none in the MF group had recurrence at one year (p = 0.18). Seroma formation, postoperative QoL and patient satisfaction scores were similar in both groups.<h4>Conclusions</h4>Use of fibrin sealant for mesh fixation does not provide significant advantage over mechanical fixation in laparoscopic IPOM repair.