Recruiting

PDS vs. Prolene

Sponsor:

Northwestern University

Code:

NCT07883122

Conditions

Inguinal Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Polypropylene suture (Prolene)

Polydioxanone suture (PDS)

Study Details

Brief summary:

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.

Conditions

Inguinal Hernia

Study ID

NCT07883122

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Prolene

Open Shouldice repair with all four layers closed using permanent polypropylene (Prolene) suture.

experimental: PDS

Open Shouldice repair with all four layers closed using slowly absorbable polydioxanone (PDS) suture.

Interventions

Polypropylene suture (Prolene)

Permanent monofilament polypropylene suture used to complete all four layers of an open Shouldice inguinal hernia repair.

Polydioxanone suture (PDS)

Slowly absorbable monofilament polydioxanone suture used to complete all four layers of an open Shouldice inguinal hernia repair.

Primary outcome measure

  • Number of Participants with Inguinal Hernia Recurrence [ Time Frame: 1 year (+/- 2 months) after surgery ]

Central Contacts and Locations

Central contacts

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Northwestern University

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Shouldice repair
  • Non-mesh hernia repair
  • Polydioxanone (PDS)
  • Polypropylene (Prolene)
  • Absorbable suture
  • Hernia recurrence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.