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
| Autor: | M Gingell-Littlejohn, Andrew N. Kingsnorth, S Smeds, S Schüle, A Eklund, P Appel, Paul Ziprin, Marc Miserez, Simon W. Nienhuijs |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Visual analogue scale Polyesters Hernia Inguinal Polypropylenes law.invention Randomized controlled trial law Recurrence Medicine Humans Surgical Wound Infection Hernia Herniorrhaphy Fixation (histology) Aged Polyester mesh Pain Postoperative Sutures business.industry Middle Aged Surgical Mesh medicine.disease Surgery Clinical trial Inguinal hernia business Abdominal surgery Follow-Up Studies |
| Zdroj: | Hernia : the journal of hernias and abdominal wall surgery. 16(3) |
| ISSN: | 1248-9204 |
| Popis: | To compare clinical outcomes following sutureless Parietex™ ProGrip™ mesh repair to traditional Lichtenstein repair with lightweight polypropylene mesh secured with sutures. 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. 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 |
| Databáze: | OpenAIRE |
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