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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Primary closure (Intervention arm) | Active Comparator | Participants will undergo incisional hernia repair with suture alone using modern surgical techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incisional hernia repair | Procedure | Participants will undergo incisional hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hernia specific quality of life | Compare HerQLes summary score at baseline, 30-day, and 2-year follow-up, and 5-year follow up | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clayton Petro, MD | Contact | 2169242930 | petroc@ccf.org | |
| William Bennett, MD | Contact | 2163138971 | bennetw2@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Clayton Petro, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41163187 | Derived | 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. |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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Participants will be blinded to intervention. Recurrence on imaging will be assessed by blinded assessors
| 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 | 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. | 5 years |
| Overall quality of life | 4. Compare Euro-QOL-5D-5L with VAS assessment scores at baseline, 30-day, 1-year, 2 years, and 5-year follow-up. | 5 years |
| Cost effectiveness | 5. Perform a formal cost effectiveness analysis utilizing quality adjusted life years and incremental cost effectiveness ratios. | 5 years |
| Northwestern | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Cleveland Clinic Main Campus | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| The Ohio State University Wexner Medical Center | Not yet recruiting | Columbus | Ohio | 43210 | United States |
|
| Vanderbilt University | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| D010335 | Pathologic Processes |