One-year outcome after open inguinal hernia repair with self-fixated mesh: a randomized controlled trial

Abstract

Abstract Purpose The aim of this study was to analyze pain after surgery with the use of self-fixated meshes, which are commonly used as an alternative for sutured mesh in open inguinal hernia repair. Methods This prospective randomized clinical trial was conducted from November 2018 to March 2021, with a follow-up duration of 12 months. Male patients, aged 18–85, and suitable for day case surgery, were included. The patients received the self-adhesive Adhesix™ mesh or the self-gripping Progrip™ mesh in open inguinal hernia surgery. The primary outcome was the number of additional follow-up visits due to post-operative pain. Secondary outcomes included intensity of pain, quality of life measures, and complications. Results Two hundred seventy patients were included in this trial, 132 with Adhesix™ (A group), and 138 with Progrip™ (P-group). All patients’ medical records were reviewed 12 months after surgery, and 207 patients (76.2%) completed 12-month follow-up. The number of patients needing additional follow-up visits 3–12 months after surgery were comparable (A group 3/3.0%, P-group 6/5.6%). The numeric rating scale was low at 12 months after surgery (at rest A 0.21, P 0.34, at exercise A 0.78, P 0.90). The incidence of chronic pain, that is moderate or severe pain during exercise, was 5 patients (5.2%) with Adhesix™ and 8 patients (7.4%) with Progrip™ (P = 0.333). Two hernia recurrences (1.0%) were established, one in each group. Conclusion At 1 year after hernia surgery, the use of self-gripping and self-adhesive meshes lead to successful pain reduction and quality of life improvement. Trial registration. ClinicalTrials.com NCT03734224.