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Erschienen in:
01.06.2012 | Original Article
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
Erschienen in: Hernia | Ausgabe 3/2012
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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.