Suture Repair vs Mesh Repair for Incisional Hernia

Clayton Petro

Status: Enrolling

Conditions: Incisional Hernia

Treatments: Procedure: Incisional hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05599750

22-945

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups

Hernia repair with mesh (Control arm)

Active Comparator group

Description:

Participants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap.

Treatment:

Procedure: Incisional hernia repair

Primary closure (Intervention arm)

Active Comparator group

Description:

Participants will undergo incisional hernia repair with suture alone using modern surgical techniques.

Treatment:

Procedure: Incisional hernia repair