A modern comparison of suture repair versus mesh repair for incisional hernia: a study protocol for a randomized controlled trial.
Sara M Maskal, Benjamin T Miller, Ryan C Ellis...
https://pubmed.ncbi.nlm.nih.gov/41163187/Actively Recruiting
Led by Clayton Petro · Updated on 2026-01-07
154
Participants Needed
5
Research Sites
260 weeks
Total Duration
Researchers are evaluating the quality of life outcomes in patients undergoing surgery for incisional hernias. This trial compares two surgical methods repair using synthetic mesh and repair using sutures alone, focusing on hernias sized 2 to 6 cm. The study is designed as a patient-blinded randomized control trial to test if suture repair is not worse than mesh repair in terms of quality of life one year after surgery. Participants will be randomly assigned to one of two groups. One group will receive incisional hernia repair with prolene mesh placed in the retrorectus position with at least 4 cm of overlap. The other group will have the hernia repaired using only sutures with modern surgical techniques. Both groups will be followed in parallel, and participants will not know which treatment they received. During the study, researchers will assess quality of life using the HerQLes survey at one year, which is the primary outcome. Secondary outcomes include long-term quality of life, pain intensity, hernia recurrence, complications, overall quality of life, and cost effectiveness measured over five years. Participants are expected to be monitored regularly for these outcomes, and the total study duration extends up to several years to observe long-term effects.
CONDITIONS
Suture Repair vs Mesh Repair for Incisional Hernia
C
Clayton Petro, MD
W
William Bennett, MD
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Clayton Petro
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Suture‑only repair | Mesh repair (trial arm) | Mesh repair (standard of care) |
|---|---|---|---|
| What it is | Suture‑only repair using posterior sheath release, small‑bite 4:1 closure technique evaluated in trial | Synthetic mesh placement in retrorectus position as comparator arm in trial | Mesh repair is widely considered the standard approach for incisional hernia repair to reduce recurrence |
| Role in trial | Investigational arm testing whether suture‑only is non‑inferior | Active comparator arm using mesh repair | Acts as standard surgical option outside trial |
| Primary use | Repair incisional hernia without prosthetic reinforcement | Restore abdominal wall integrity with mesh reinforcement | Reinforce repair with mesh to lower long‑term hernia recurrence |
| Procedure technique | Posterior rectus sheath release and small‑bite running suture with 4:1 closure ratio | Retrorectus placement of synthetic mesh with overlap | Standard mesh placement techniques include retrorectus, underlay or onlay overlap |
| Evidence status | Under investigation for non‑inferiority in this trial; no published outcomes yet | Widely used with evidence of lower recurrence compared to suture repair | Established approach with consistent support for reduced recurrence |
| Important risks | Risks not yet defined; awaiting trial safety results | Potential for surgical‑site infection or seroma | Infection, seroma or mesh complications such as chronic pain or erosion are possible |
| Important limitations | Effectiveness and safety are not yet known; trial results pending | Mesh may reduce recurrence but may lead to higher short‑term wound events | Long‑term complications, quality‑of‑life impact, and mesh‑related risks are areas of ongoing evaluation |
| Patient impact | Unknown; trial aims to assess quality‑of‑life outcomes at one year | May reduce hernia recurrence but with short‑term wound morbidity; long‑term quality‑of‑life trade‑offs uncertain | Standard treatment with reduced recurrence, but patients may experience wound‑related side effects or long‑term mesh‑related issues |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day to 2 weeks or until discharge
Participants undergo incisional hernia repair surgery using either synthetic mesh or suture repair and receive immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - Up to 5 years
Participants are followed after surgery to monitor recovery, quality of life, and any complications.
Periodic visits over 5 years for assessments
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sara M Maskal, Benjamin T Miller, Ryan C Ellis...
https://pubmed.ncbi.nlm.nih.gov/41163187/Clayton Petro
Lead Sponsor