An interventional study of Polypropylene suture (Prolene) and Polydioxanone suture (PDS) in Inguinal Hernia, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether slowly dissolving stitches work as well as permanent stitches for repairing a groin (inguinal) hernia in adults using the Shouldice technique, a hernia repair that does not use mesh. Researchers think dissolving stitches may cause less long-term groin discomfort without making the hernia more likely to come back. The main questions it aims to answer are:
Is the chance of the hernia coming back within 1 year different with dissolving stitches (PDS) compared with permanent stitches (Prolene)?
Do the two types of stitches differ in complications, groin pain, quality of life, or the feeling of something foreign in the groin?
Is a larger future study of this question possible? This includes whether enough people join, whether the study plan is followed, and whether participants complete follow-up.
Researchers will compare slowly dissolving polydioxanone (PDS) stitches with permanent polypropylene (Prolene) stitches to see if the hernia comes back at similar rates and if patients have less long-term discomfort.
Participants will:
Have their planned open Shouldice hernia repair. The type of stitch will be chosen at random, like flipping a coin, during surgery.
Not be told which stitch they received until 1 year after surgery, or sooner if the hernia comes back or another operation is needed.
Complete questionnaires about pain, activity, and quality of life before surgery and about 30 days, 6 months, and 1 year after surgery.
See their surgeon for routine visits about 30 days and 1 year after surgery.
Receive one research phone call about 6 months after surgery.
Answer whether they feel something foreign in their groin and which type of stitch they think they received.
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.
561 studies on the registry are indexed under Hernia, Inguinal; 76 are open to participants now.
This study's planned enrollment of 200 is above the median of 90 across 414 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Open Shouldice repair with all four layers closed using permanent polypropylene (Prolene) suture.
Device: Polypropylene suture (Prolene)
Open Shouldice repair with all four layers closed using slowly absorbable polydioxanone (PDS) suture.
Device: Polydioxanone suture (PDS)
Permanent monofilament polypropylene suture used to complete all four layers of an open Shouldice inguinal hernia repair.
Slowly absorbable monofilament polydioxanone suture used to complete all four layers of an open Shouldice inguinal hernia repair.
Number of Participants with Inguinal Hernia Recurrence
Recurrent inguinal hernia identified on clinical examination and confirmed by imaging.
Time frame: 1 year (+/- 2 months) after surgery
Postoperative Complications (wound complications, readmissions, reoperations)
Postoperative complications, including wound complications, readmissions, and reoperations.
Time frame: 30 days (+/- 15 days) and 1 year (+/- 2 months) after surgery
EuraHS-QoL (European Registry for Abdominal Wall Hernias Quality of Life) Total Score
Patient-reported quality of life measured with the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS-QoL) score. The total score ranges from 0 to 90; higher scores indicate worse quality of life.
Time frame: Baseline (preoperative), 30 days, 6 months, and 12 months after surgery
EuraHS-QoL Pain Domain Score
Groin pain measured with the pain domain of the EuraHS-QoL questionnaire (3 items). The domain score ranges from 0 to 30; higher scores indicate worse pain.
Time frame: 6 and 12 months after surgery
Number of Participants Reporting Foreign Body Sensation
Number of participants reporting a foreign body sensation in the groin, assessed with a single yes/no question.
Time frame: 30 days, 6 months, and 12 months after surgery
Number of Participants Who Believe They Received Permanent Suture
Participants are asked which suture type they believe was used in their repair.
Time frame: 30 days, 6 months, and 12 months after surgery
Enrollment Rate
Mean number of participants randomized per month of active enrollment, from first to last randomization.
Time frame: From study start through end of enrollment, approximately 12 months
Number of Participants Receiving the Allocated Suture Repair
Number of randomized participants whose Shouldice repair was completed using the allocated suture (Prolene or PDS) in all four layers.
Time frame: Day of surgery
Number of Participants Completing the 12-Month Recurrence Assessment and All Scheduled EuraHS-QoL Questionnaires
Each participant is classified as having complete or incomplete follow-up. Complete follow-up requires both attendance at the 12-month visit with a hernia recurrence assessment and completion of the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS-QoL) questionnaire at 30 days, 6 months, and 12 months. The total score for the EuraHS-QoL ranges from 0 to 90; higher scores indicate worse quality of life. The number of participants with complete follow-up is reported.
Time frame: 12 months after surgery (+/- 2 months)
Plan to share: No — Individual participant data will not be shared publicly. Data will be used by the study team for analysis and reporting of aggregate results only.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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