Inguinal HerniaNCT07883122
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
A study testing Polypropylene suture (Prolene) and Polydioxanone suture (PDS) in people with Inguinal Hernia, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Polypropylene suture (Prolene) and Polydioxanone suture (PDS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Megan Melland-Smith, MD, 312-695-6868, megan.mellandsmith@nm.org
Maria Narvaez Pereyra, MD, 561-271-5655, maria.narvaezpereyra@northwestern.edu
About this study
Official title: Comparing Permanent Polypropylene (Prolene) Versus Slowly Absorbable Polydioxanone (PDS) Suture in Open Shouldice Inguinal Hernia Repair: A Pilot Randomized Controlled Trial
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)?
Read more
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.
Read the detailed description
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.
- Conditions
- Inguinal Hernia
- Being tested
- Polypropylene suture (Prolene), Polydioxanone suture (PDS)
- Keywords
- Shouldice repair, Non-mesh hernia repair, Polydioxanone (PDS), Polypropylene (Prolene), Absorbable suture, Hernia recurrence
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypropylene suture (Prolene)Device
Permanent monofilament polypropylene suture used to complete all four layers of an open Shouldice inguinal hernia repair.
Polydioxanone suture (PDS)Device
Slowly absorbable monofilament polydioxanone suture used to complete all four layers of an open Shouldice inguinal hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| Prolene | Active comparator | Open Shouldice repair with all four layers closed using permanent polypropylene (Prolene) suture. Receives: Device: Polypropylene suture (Prolene) |
| PDS | Experimental | Open Shouldice repair with all four layers closed using slowly absorbable polydioxanone (PDS) suture. Receives: Device: Polydioxanone suture (PDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Inguinal Hernia Recurrence
Recurrent inguinal hernia identified on clinical examination and confirmed by imaging.
Measured: 1 year (+/- 2 months) after surgery
Secondary outcomes (8)
Postoperative Complications (wound complications, readmissions, reoperations)
Postoperative complications, including wound complications, readmissions, and reoperations.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after surgery (+/- 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Melland-Smith, Northwestern University
- Investigators
- Megan Melland-Smith, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883122
- Sponsor's protocol ID
- STU00226002
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Publications
Paasch C, Mainprize M, Hunger R, Netto FACS. Polypropylene vs. stainless-steel wire suture: short-term recurrence rate after shouldice primary inguinal hernia repair, a non-inferior analysis among 1120 patients. A case-control study. Hernia. 2024 Dec;28(6):2177-2186. doi: 10.1007/s10029-024-03110-z. Epub 2024 Aug 29.
PubMed 39210196Mainprize M, Spencer Netto FAC, Degani C, Szasz P. The Shouldice Method: an expert's consensus. Hernia. 2023 Feb;27(1):147-156. doi: 10.1007/s10029-022-02658-y. Epub 2022 Aug 8.
PubMed 35939246
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Permanent Polypropylene (Prolene) Versus Slowly Absorbable Polydioxanone (PDS) Suture in Open Shouldice Inguinal Hernia Repair: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07883122
- Acronym / sponsor ID
- STU00226002
- Conditions
- Inguinal Hernia
- Keywords
- Shouldice repair, Non-mesh hernia repair, Polydioxanone (PDS), Polypropylene (Prolene), Absorbable suture, Hernia recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolene | Active comparator | Device: Polypropylene suture (Prolene)Open Shouldice repair with all four layers closed using permanent polypropylene (Prolene) suture. |
| PDS | Experimental | Device: Polydioxanone suture (PDS)Open Shouldice repair with all four layers closed using slowly absorbable polydioxanone (PDS) suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Urgent or emergent presentations
- Contaminated cases
- Prior inguinal hernia repairs done on side of presenting symptomatic hernia
- Femoral hernias
- Adults unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polypropylene suture (Prolene)Permanent monofilament polypropylene suture used to complete all four layers of an open Shouldice inguinal hernia repair. | Device | Prolene |
| Polydioxanone suture (PDS)Slowly absorbable monofilament polydioxanone suture used to complete all four layers of an open Shouldice inguinal hernia repair. | Device | PDS |
Primary outcome
Number of Participants with Inguinal Hernia Recurrence
Time frame: 1 year (+/- 2 months) after surgery
Recurrent inguinal hernia identified on clinical examination and confirmed by imaging.
8 secondary outcomes
Postoperative Complications (wound complications, readmissions, 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
Time frame: Baseline (preoperative), 30 days, 6 months, and 12 months after surgery
EuraHS-QoL Pain Domain Score
Time frame: 6 and 12 months after surgery
Number of Participants Reporting Foreign Body Sensation
Time frame: 30 days, 6 months, and 12 months after surgery
Number of Participants Who Believe They Received Permanent Suture
Time frame: 30 days, 6 months, and 12 months after surgery
Enrollment Rate
Time frame: From study start through end of enrollment, approximately 12 months
Number of Participants Receiving the Allocated Suture Repair
Time frame: Day of surgery
Number of Participants Completing the 12-Month Recurrence Assessment and All Scheduled EuraHS-QoL Questionnaires
Time frame: 12 months after surgery (+/- 2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 39210196Paasch C, Mainprize M, Hunger R, Netto FACS. Polypropylene vs. stainless-steel wire suture: short-term recurrence rate after shouldice primary inguinal hernia repair, a non-inferior analysis among 1120 patients. A case-control study. Hernia. 2024 Dec;28(6):2177-2186. doi: 10.1007/s10029-024-03110-z. Epub 2024 Aug 29.
- Background: PubMed 35939246Mainprize M, Spencer Netto FAC, Degani C, Szasz P. The Shouldice Method: an expert's consensus. Hernia. 2023 Feb;27(1):147-156. doi: 10.1007/s10029-022-02658-y. Epub 2022 Aug 8.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Melland-Smith, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polypropylene suture (Prolene) and Polydioxanone suture (PDS) in people with Inguinal Hernia, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Melland-Smith, MD (312-695-6868, megan.mellandsmith@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Inguinal Hernia Recurrence (time frame: 1 year (+/- 2 months) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07883122, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.