Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorNorthwestern University
Academic / other
Locations1 site (Chicago, Illinois)
StatusRecruiting
StartedOctober 26, 2026
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedNovember 6, 2026
Trial IDNCT07883122 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.