Randomized clinical trial comparing self-gripping mesh with a standard polypropylene mesh for open inguinal hernia repair.

Abstract

The introduction of mesh for open inguinal hernia repair has reduced the rate of recurrence, allowing research to focus on prevention of postoperative pain. In an effort to reduce chronic pain, a semiresorbable, lighter and self-gripping mesh was developed. A double-blind randomized clinical trial was conducted comparing the self-gripping mesh with a standard polypropylene mesh repair. Patients over 18 years of age undergoing open primary hernia repair were included. Pain was measured on a six-point verbal rating scale (VRS) and a 150-mm visual analogue scale (VAS). Postoperative pain reduction from baseline pain (ΔVAS), complications and return to work/hobbies were studied. Data were collected at baseline, 3 weeks, 3 months and 1 year after surgery (primary outcome). A total of 363 patients were analysed. Median age was 59 (range 19-88) years. Baseline VRS and VAS scores were similar for the two groups. There was no difference in VRS scores at 1-year follow-up. Duration of surgery was significantly shorter with the self-gripping mesh (mean 40 min versus 49 min for standard mesh repair; P < 0·001). At 3 weeks, ΔVAS in patients receiving the self-gripping mesh was significantly larger (-10·6 versus -5·0 respectively; P = 0·049) and less subjective discomfort was reported (P = 0·016). Complication rates, return to work and recurrence rates were similar, although there were more recurrences in the self-gripping mesh group (5·5 versus 2·2 per cent; P = 0·103). A self-gripping mesh for hernia repair may result in less pain in the early postoperative phase but chronic postherniorraphy pain is not affected. Recurrence rates may be a potential disadvantage. NTR1212 (http://www.trialregister.nl).