A single-blind, randomized study comparing clinical equivalence of Trulene® polypropylene mesh to Prolene® polypropylene mesh in subjects undergoing lichtenstein open repair of primary inguinal hernia secured with sutures

Abstract

BACKGROUND: Inguinal hernia is the most frequently diagnosed abdominal wall hernia. Lichtenstein open repair involving mesh fixation lowers the recurrence rate and risk of postoperative complications. This study compared the clinical equivalence of Trulene® polypropylene mesh (Healthium Medtech Limited) and Prolene® (Ethicon-Johnson & Johnson) polypropylene mesh with respect to recurrence rate of hernia in subjects undergoing Lichtenstein open repair of primary inguinal hernia, secured with sutures. MATERIALS AND METHODS: Between September 2020 and November 2022, this multicentric, randomized (1:1), single-blind, prospective, two-arm, parallel-group study (n = 120) was conducted. The primary study endpoint, proportion of subjects having recurrence of hernia within 6 and 12 months of index surgery, was assessed. The secondary endpoints, pain score, number of analgesics, postoperative complications, operative time, length of hospital stay, need for readmission, time to resume back to normal activities and return to work, other adverse events, subject satisfaction score, and quality of life (QOL) postoperatively were also recorded. RESULTS: During the 12-month follow-up period, no recurrence of hernia was recorded. In addition, no significant differences regarding intraoperative mesh parameters, pain score, number of analgesics, postoperative complications, operative time, length of hospital stay, readmission, time to resume normal activities and return to work, and subject satisfaction score and QOL were recorded between Trulene® and Prolene® mesh groups. CONCLUSION: Trulene® polypropylene mesh is clinically equivalent to Prolene® polypropylene mesh. Both meshes are safe and effective for Lichtenstein open repair of primary inguinal hernia with minimal risk of hernia recurrence and chronic pain.