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NCT Number: NCT05599750

Suture Repair vs 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.

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Key information

Conditions

Incisional Hernia Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

incisional hernia repair

Procedure

Participants will undergo incisional hernia repair

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hernia specific quality of life

    Time frame: 5 years

    Compare HerQLes summary score at baseline, 30-day, and 2-year follow-up, and 5-year follow up

  2. PROMIS-3a-Pain Intensity scores

    Time frame: 5 years

    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.

  3. Recurrence

    Time frame: 5 years

    Compare composite recurrence using clinical, radiographic exam, and Hernia Recurrence Inventory (HRI) at 1-year, and 2-year, and 5 year follow-up postoperatively

  4. Complications

    Time frame: 5 years

    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. Overall quality of life

    Time frame: 5 years

    • Compare Euro-QOL-5D-5L with VAS assessment scores at baseline, 30-day, 1-year, 2 years, and 5-year follow-up.

  6. Cost effectiveness

    Time frame: 5 years

    • Perform a formal cost effectiveness analysis utilizing quality adjusted life years and incremental cost effectiveness ratios.

Study contacts

Contact information is provided by the study sponsor or research team.

Clayton Petro, MD

CONTACT

[email protected]

2169242930

William Bennett, MD

CONTACT

[email protected]

2163138971

Sponsors and collaborators

Lead sponsor

Clayton Petro

Other

Registry information

Official study title

A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia

Important dates

Study start
2022
Primary completion
2026
Study completion
2031
First posted
Oct 31, 2022
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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