Shouldice groin hernia repair: permanent vs slowly dissolving stitches
Official title: Comparing Permanent Polypropylene (Prolene) Versus Slowly Absorbable Polydioxanone (PDS) Suture in Open Shouldice Inguinal Hernia Repair: A Pilot Randomized Controlled Trial
Run by Northwestern University · NCT07883122 · Data updated 2026-11-12
We’re testing whether slowly dissolving stitches (PDS) work as well as permanent stitches (Prolene) for adults with a non-mesh Shouldice inguinal hernia repair.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | October 26, 2026 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07883122 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ with a symptomatic unilateral inguinal hernia eligible for Shouldice repair and who can consent and speak English.
✕Probably not a fit
Patients who do not fit the criteria or have factors increasing recurrence risk may not benefit from changing suture type.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized study compares two suture types in the Shouldice non-mesh groin hernia repair. Participants are adults with a symptomatic unilateral inguinal hernia, enrolled across sites and randomized intraoperatively after dissection. The main outcomes look at hernia recurrence within one year, complications, groin pain, quality of life, and foreign-body sensation, using intention-to-treat analysis. The trial also assesses feasibility for a larger future non-inferiority study, including recruitment and follow-up completeness. Both sutures are FDA-cleared and the trial is designed to inform optimal suture choice in Shouldice repairs.
Why it matters
Potential benefit: If dissolving stitches perform as well as permanent ones, patients may experience less long-term groin discomfort while maintaining hernia repair strength.
How similar studies have gone: The approach explores a previously routine technique with different sutures; prior data on long-term outcomes in this exact comparison are limited, making this a novel/limitedly established area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients 18 years or older * Symptomatic unilateral inguinal hernia * BMI 30 or less * Ability to provide informed consent * Must speak and understand English Exclusion Criteria: * Urgent or emergent presentations * Contaminated cases * Prior inguinal hernia repairs done on side of presenting symptomatic hernia * Femoral hernias * Adults unable to consent * Pregnant patients * Bilateral inguinal hernia repairs
Where it's running
-
Northwestern Memorial Hospital
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Megan Melland-Smith, MD — Northwestern University
- Study coordinator: Megan Melland-Smith, MD
- Email: megan.mellandsmith@nm.org
- Phone: 312-695-6868
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Two laparoscopic techniques for repairing inguinal hernias in children
This study tests whether LPEC or LIS works better for repairing inguinal hernias in children aged 1 to 15 who need laparoscopic repair.
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Acupressure for Postoperative Pain After Laparoscopic TEP Hernia Repair
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TREPP: A Minimally Invasive Open Approach to Repair Inguinal Hernias
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Camera-based non-contact vital sign monitoring during surgery
This project will try a camera-based non-contact system to measure heart rate, blood pressure, and oxygen levels in adults having surgery under general anesthesia.
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Pneumoperitoneum time and bicarbonate changes during laparoscopic inguinal hernia repair
This study will see if longer pneumoperitoneum time during laparoscopic inguinal hernia repair causes changes in blood bicarbonate levels in adults.
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This trial will test whether ultrasound-guided transversus abdominis plane (TAP) and/or rectus sheath (RS) nerve blocks reduce opioid use and speed recovery in adults having open unilateral inguinal hernia repair.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.