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, 04/02/2012

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.

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.

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