Randomized controlled multicenter international clinical trial of self-gripping Parietex™ProGrip™polyester mesh versus lightweight polypropylene mesh in open inguinal hernia repair: Interim Results at 3 months

Abstract

Purpose To compare clinical outcomes following sutureless Parietex™ProGrip™mesh repair to traditional Lichtenstein repair with lightweight polypropylene mesh secured with sutures. Methods This is a 3-month interim report of a 1-year multicenter international study. Three hundred and two patients were randomized; 153 were treated with Lichtenstein repair (L group) and 149 with Parietex™ProGrip™ precut mesh (P group) with or without fixation. The primary outcome measure was postoperative pain using the visual analog scale (VAS, 0-150 mm); other outcomes were assessed prior to surgery and up to 3 months postoperatively. Results Compared to baseline, pain score was lower in the P group at discharge (-10%) and at 7 days (-13%), while pain increased in the L group at discharge (+39%) and at 7 days (+21%). The difference between groups was significant at both time points (P = 0.007 and P = 0.039, respectively). In the P group, patients without fixation suffered less pain compared to those with single-suturefixation (1 month: -20.9 vs. -6.15%, P = 0.02;3 months: -24.3 vs. -7.7%, P = 0.01). The infection ratewas significantly lower in the P group during the 3-monthfollow-up (2.0 vs. 7.2%, P = 0.032). Surgery duration was significantly shorter in the P group (32.4 vs. 39.1 min; P<0.001). No recurrence was observed at 3 months inboth groups.Conclusions Surgery duration, early postoperative, painand infection rates were significantly reduced with selfgripping polyester mesh compared to Lichtenstein repair with polypropylene mesh. The us e of fixation increased postoperative pain in the P group. The absence of early recurrence highlights the gripping efficiency effect. © Springer-Verlag 2012.