Randomized controlled multicenter international clinical trial of self-gripping Parietex (TM) ProGrip (TM) polyester mesh versus lightweight polypropylene mesh in open inguinal hernia repair: interim results at 3 months
2012 (English)In: Hernia, ISSN 1265-4906, E-ISSN 1248-9294, Vol. 16, no 3, 287-294 p.Article in journal (Refereed) Published
Purpose: To compare clinical outcomes following sutureless Parietex (TM) ProGrip (TM) 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 (TM) ProGrip (TM) 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-suture fixation (1 month: -20.9 vs. -6.15%, P = 0.02; 3 months: -24.3 vs. -7.7%, P = 0.01). The infection rate was significantly lower in the P group during the 3-month follow-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 in both groups.
Conclusion: Surgery duration, early postoperative, pain and infection rates were significantly reduced with self-gripping polyester mesh compared to Lichtenstein repair with polypropylene mesh. The use of fixation increased postoperative pain in the P group. The absence of early recurrence highlights the gripping efficiency effect.
Place, publisher, year, edition, pages
2012. Vol. 16, no 3, 287-294 p.
Parietex (TM) ProGrip (TM), Lichtenstein, Polyester mesh, Polypropylene mesh, Lightweight mesh, Self-gripping mesh
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:uu:diva-176813DOI: 10.1007/s10029-012-0900-yISI: 000304611700008OAI: oai:DiVA.org:uu-176813DiVA: diva2:537731