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Suture Repair vs Mesh Repair for Incisional Hernia

ConditionIncisional Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClayton Petro

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults >18 years old.

Anticipated hernia defect 2-6cm in width

Non-emergent case

CDC class I

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Incisional hernia repair

    Procedure/Surgery

    Participants will undergo incisional hernia repair

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: Hernia repair with mesh (Control arm)Active comparator 1 intervention
Group B: Primary closure (Intervention arm)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

Hernia specific quality of life

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

Time frame
5 years
2

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.

Time frame
5 years
3

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

Time frame
5 years
4

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.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clayton Petro

Lead sponsor

The Cleveland Clinic

Sponsor institution

Source ClinicalTrials.gov
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