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

Hernia. 2012 Jun;16(3):287-94. doi: 10.1007/s10029-012-0900-y. Epub 2012 Mar 28.

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-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.

Conclusions: 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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Follow-Up Studies
  • Hernia, Inguinal / surgery*
  • Herniorrhaphy / adverse effects*
  • Herniorrhaphy / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Pain, Postoperative / etiology*
  • Polyesters / adverse effects
  • Polypropylenes / adverse effects
  • Recurrence
  • Surgical Mesh / adverse effects*
  • Surgical Wound Infection / etiology
  • Sutures / adverse effects
  • Time Factors

Substances

  • Polyesters
  • Polypropylenes