Primary closure (Intervention arm) for Incisional Hernia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Incisional Hernia+3 MoreIncisional hernia repair - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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. 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.

Eligible Conditions
  • Incisional Hernia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 5 years

1 year
Quality of life
5 years
Complications
Cost effectiveness
Diaphragmatic Hernia
Overall quality of life
Pain
Pain
Recurrence

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Primary closure (Intervention arm)
1 of 2
Hernia repair with mesh (Control arm)
1 of 2

Active Control

154 Total Participants · 2 Treatment Groups

Primary Treatment: Primary closure (Intervention arm) · No Placebo Group · N/A

Primary closure (Intervention arm)
Procedure
ActiveComparator Group · 1 Intervention: Incisional hernia repair · Intervention Types: Procedure
Hernia repair with mesh (Control arm)
Procedure
ActiveComparator Group · 1 Intervention: Incisional hernia repair · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
949 Previous Clinical Trials
1,409,598 Total Patients Enrolled
4 Trials studying Incisional Hernia
493 Patients Enrolled for Incisional Hernia
Clayton Petro, MDPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
150 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a non-emergent case.
Patients who previously underwent primary ventral hernia repair without the use of mesh.