Feasibility and Efficacy of Desarda vs Lichtenstein Hernioplasty by Local Anesthesia for Inguinal Hernia Repair: A Noninferiority Randomized Clinical Trial

Abstract

Introduction: Lichtenstein repair is a standard open technique for inguinal hernia but needs a prosthesis, increasing cost and complication. Conversely, Desarda autologous tissue repair is reported to have comparable results. This study aims to compare the efficacy of Desarda repair (DR) with Lichtenstein’s hernioplasty (LH) and establish the feasibility of operation under local anaesthesia (LA). Methods: This study was a prospective, double-blinded, non-inferiority randomized trial in patients undergoing open inguinal hernia repair under LA [NCT03512366]. The non-inferiority margin fixed was 0.5 days. The primary endpoint was time to return to the normal gait with comfort postoperative. The secondary endpoints studied were the incidence of surgical site occurrences (SSO), including recurrence. Results: The cohort comprised 56 patients (50.9%) in the DR group and 54 patients (49.1%) in the LH group. All the procedures were safely performed under LA. By intention-to-treat analysis, the median (interquartile range) duration for resuming gait post-surgery with comfort was 5 (interquartile range [IQR], 3-8) days in the DR vs 4 (IQR, 3-7) days in the LH arm (P = 0.16), thereby failing to demonstrate the noninferiority. There was no significant difference in days to return to work, surgical site occurrences, chronic groin pain, and two years recurrence rates. Conclusion: This study could not statistically prove the noninferiority of Desarda repair compared with Lichtenstein hernioplasty for resuming normal gait. Still, comparing the days to return to work, pain score, chronic groin pain and recurrence rate, Desarda repair faired equally with Lichtenstein hernioplasty, thereby highlighting its feasibility under local anaesthesia and efficacy.