title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Surgery, Derriford Hospital, Derriford Road, GB-Plymouth, PL6, UK. andrew.kingsnorth@nhs.net
authors.forename: A
authors.initials: A
authors.lastname: Kingsnorth
authors.forename: M
authors.initials: M
authors.lastname: Gingell-Littlejohn
authors.forename: S
authors.initials: S
authors.lastname: Nienhuijs
authors.forename: S
authors.initials: S
authors.lastname: Schüle
authors.forename: P
authors.initials: P
authors.lastname: Appel
authors.forename: P
authors.initials: P
authors.lastname: Ziprin
authors.forename: A
authors.initials: A
authors.lastname: Eklund
authors.forename: M
authors.initials: M
authors.lastname: Miserez
authors.forename: S
authors.initials: S
authors.lastname: Smeds
mesh_terms: D000328:Adult; D000368:Aged; D005500:Follow-Up Studies; D006552:Hernia, Inguinal / Q000601:surgery*; D059685:Herniorrhaphy / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology*; D011091:Polyesters / Q000009:adverse effects; D011126:Polypropylenes / Q000009:adverse effects; D012008:Recurrence; D013526:Surgical Mesh / Q000009:adverse effects*; D013530:Surgical Wound Infection / Q000209:etiology; D013537:Sutures / Q000009:adverse effects; D013997:Time Factors
chemical_list: D011091:Polyesters; D011126:Polypropylenes