Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair

Background: Chronic groin pain after mesh repair of inguinal hernia has been attributed to the presence of sutures. Methods: This randomized clinical trial compared inguinal hernia repair using a self-fixating composite mesh or a sutured lightweight mesh, with pain at 1 year as primary outcome. Patients completed a self-evaluation questionnaire at 2 weeks and were examined after 1 year. Results: Some 198 patients received self-fixatingmesh and 196 sutured mesh. There were no differences between the groups in mean pain scores measured on a visual analogue scale during 2 weeks of immediate convalescence or at 1 year. Chronic pain and discomfort was experienced by 36.3 per cent of patients in the self-fixating and 34.1 per cent in the sutured mesh group (P = 0.658), affecting the everyday life of 1.1 and 2.8 per cent respectively (P = 0.448). Conclusion: Open inguinal hernia repair with a composite self-fixating mesh resulted in similar pain in the early postoperative convalescence period and at 1 year as repair with a sutured lightweight mesh. Registration number: NCT01026935 (http://www.clinicaltrials.gov).