Background: The Shouldice repair is a non-mesh inguinal hernia repair that reconstructs the posterior inguinal wall in four continuous suture layers. It is traditionally performed with permanent suture. Permanent suture leaves foreign material in the groin that may contribute to foreign body sensation and chronic groin pain. Slowly absorbable polydioxanone retains tensile strength through the early healing period before it is absorbed. Stainless-steel sutures used in Shouldice repairs have been observed to fracture over time. This raises the possibility that permanent suture strength may not be required once tissue healing is complete.
Conduct: Randomization is centralized across all sites, using block randomization with a fixed block size of 4. It takes place intraoperatively after hernia dissection and sac reduction.
Analysis: The primary analysis is intention-to-treat. Feasibility is defined as successful delivery of the allocated repair with complete data collection in at least 80% of participants, considered acceptable if within 5 percentage points of that target. The trial is not powered for formal hypothesis testing of recurrence. Its purpose is to inform the design of a definitive multicenter non-inferiority trial.
Safety: Procedure- and suture-related adverse events are reviewed weekly by the investigators. No independent data monitoring committee is planned because both sutures are FDA-cleared and used on-label in an established operation. Enrollment will be suspended if a safety signal or a between-arm imbalance in recurrence or complications emerges.
