Penetrating fixation device versus fibrin sealant for mesh fixation in laparoscopic repair of ventral hernia: a randomized controlled trial
摘要
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.
MethodsThis 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.
ResultsThere 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.
ConclusionsUse of fibrin sealant for mesh fixation does not provide significant advantage over mechanical fixation in laparoscopic IPOM repair.