Incisional HerniaNCT05599750
Suture Repair vs Mesh Repair for Incisional Hernia
A study testing Incisional hernia repair in people with Incisional Hernia, run by Clayton Petro at 5 sites in United States.
Trial summary
The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Incisional hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Nov 2022to Oct 2031
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults >18 years old.
- Anticipated hernia defect 2-6cm in width
- Non-emergent case
- CDC class I
- Patients who previously underwent primary ventral hernia repair without the use of mesh
- Incisional hernia
Who cannot join
- Emergent cases
- Patients < 18 years old
- Patients who are pregnant
- Patients who previously underwent a prior ventral hernia repair with mesh at the site of the intended repair. Abdominal mesh in separate locations would be allowed.
- Ventral hernia <2cm or > 6 cm in width
- Primary hernia
- CDC wound class II-IV
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Northwestern
Chicago, Illinois, 60611
Michael J Rosen, MD, 312-695-4835, michael.rosen@nm.org
Harika Reddy, MPH, 312-503-3929, harika.reddy@northwestern.edu
- Recruiting
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
William Bennett, MD, 216-313-8971, bennetw2@ccf.org
- Not yet recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Benjamin Poulose, MD, benjamin.poulose@osumc.edu
Kayla Diaz, kayla.diaz@osumc.edu
- Recruiting
University of Florida
Gainesville, Florida, 32611
Mazen Al-Mansour, MD, mazen.al-mansour@surgery.ufl.edu
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37232
Richard Pierce, MD, PhD
About this study
Official title: A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia
The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques.
The main question it aims to answer are:
- Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.
Read the detailed description
This is a patient-blinded randomized control trial comparing incisional hernia repair using synthetic mesh versus suture repair. This is a non-inferiority trial theorizing that suture repair will be non-inferior with respect to quality of life (using the HerQLes survey) at 1 year postoperatively. Patients will be blinded to the intervention, groups will be in parallel.
- Conditions
- Incisional Hernia
- Being tested
- Incisional hernia repair
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional hernia repairProcedure or surgery
Participants will undergo incisional hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Hernia repair with mesh (Control arm) | Active comparator | Participants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap. Receives: Procedure: Incisional hernia repair |
| Primary closure (Intervention arm) | Active comparator | Participants will undergo incisional hernia repair with suture alone using modern surgical techniques. Receives: Procedure: Incisional hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia specific quality of life
Suture repair will be compared to mesh repair for incisional hernias 2-6cm with respect to quality of life using the Hernia-specific Quality of Life (HerQLes) summary score at one year postoperatively. This is reported as a score from 0-100 with higher numbers indicating better quality of life.
Measured: 1 year
Secondary outcomes (6)
Hernia specific quality of life
Compare HerQLes summary score at baseline, 30-day, and 2-year follow-up, and 5-year follow up
Measured: 5 years
PROMIS-3a-Pain Intensity scores
Compare PROMIS-3a-Pain Intensity scores (a validated measure of pain) at baseline, 30-day, 1-year, 2 years, and 5- year follow up. Scores are reported as raw values from 3-15 or as T-scores from 30.7-71.8, with higher numbers indicating more pain.
Measured: 5 years
Recurrence
Compare composite recurrence using clinical, radiographic exam, and Hernia Recurrence Inventory (HRI) at 1-year, and 2-year, and 5 year follow-up postoperatively
Measured: 5 years
Complications
Compare all complications at 30-day, 1-year, 2-year, and 5-year follow-up postoperatively. This includes occurrence of surgical site infections, surgical site occurrence requiring intervention, readmissions, hernia related reoperation, or mortality.
Measured: 5 years
Overall quality of life
- Compare Euro-QOL-5D-5L with VAS assessment scores at baseline, 30-day, 1-year, 2 years, and 5-year follow-up.
Measured: 5 years
Cost effectiveness
- Perform a formal cost effectiveness analysis utilizing quality adjusted life years and incremental cost effectiveness ratios.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start14 Nov 2022
- Primary completionOct 2026 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clayton Petro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clayton Petro, The Cleveland Clinic
- Investigators
- Clayton Petro, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599750
- Sponsor's protocol ID
- 22-945
- Status last verified
- Nov 2025
- First submitted
- 26 Oct 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maskal SM, Miller BT, Ellis RC, Beffa LRA, Prabhu AS, Rosen MJ, Krpata DM, Huang LC, Petro CC. A modern comparison of suture repair versus mesh repair for incisional hernia: a study protocol for a randomized controlled trial. Trials. 2025 Oct 29;26(1):450. doi: 10.1186/s13063-025-08924-5.
PubMed 41163187
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia
- ClinicalTrials.gov ID
- NCT05599750
- Acronym / sponsor ID
- 22-945
- Conditions
- Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Clayton PetroUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 31 Oct 2022 (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 randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques.
The main question it aims to answer are:
- Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.
Detailed description
This is a patient-blinded randomized control trial comparing incisional hernia repair using synthetic mesh versus suture repair. This is a non-inferiority trial theorizing that suture repair will be non-inferior with respect to quality of life (using the HerQLes survey) at 1 year postoperatively. Patients will be blinded to the intervention, groups will be in parallel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hernia repair with mesh (Control arm) | Active comparator | Procedure: Incisional hernia repairParticipants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap. |
| Primary closure (Intervention arm) | Active comparator | Procedure: Incisional hernia repairParticipants will undergo incisional hernia repair with suture alone using modern surgical techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults >18 years old.
- Anticipated hernia defect 2-6cm in width
- Non-emergent case
- CDC class I
- Patients who previously underwent primary ventral hernia repair without the use of mesh
Key exclusion criteria (7 listed)
- Emergent cases
- Patients < 18 years old
- Patients who are pregnant
- Patients who previously underwent a prior ventral hernia repair with mesh at the site of the intended repair. Abdominal mesh in separate locations would be allowed.
- Ventral hernia <2cm or > 6 cm in width
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 |
|---|---|---|
| Incisional hernia repairParticipants will undergo incisional hernia repair | Procedure or surgery | Hernia repair with mesh (Control arm), Primary closure (Intervention arm) |
Primary outcome
Hernia specific quality of life
Time frame: 1 year
Suture repair will be compared to mesh repair for incisional hernias 2-6cm with respect to quality of life using the Hernia-specific Quality of Life (HerQLes) summary score at one year postoperatively. This is reported as a score from 0-100 with higher numbers indicating better quality of life.
6 secondary outcomes
Hernia specific quality of life
Time frame: 5 years
PROMIS-3a-Pain Intensity scores
Time frame: 5 years
Recurrence
Time frame: 5 years
Complications
Time frame: 5 years
Overall quality of life
Time frame: 5 years
Cost effectiveness
Time frame: 5 years
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 7 Jan 2026.
- Derived from this study: PubMed 41163187Maskal SM, Miller BT, Ellis RC, Beffa LRA, Prabhu AS, Rosen MJ, Krpata DM, Huang LC, Petro CC. A modern comparison of suture repair versus mesh repair for incisional hernia: a study protocol for a randomized controlled trial. Trials. 2025 Oct 29;26(1):450. doi: 10.1186/s13063-025-08924-5.
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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.
Clayton Petro, MD principal investigator
The Cleveland Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incisional hernia repair in people with Incisional Hernia, run by Clayton Petro at 5 sites 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 6 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Clayton Petro, MD (2169242930, petroc@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia specific quality of life (time frame: 1 year). 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 NCT05599750, which also lists 1 linked publication.
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 7 Jan 2026.