Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation

NeuroTherapia, Inc.

Status: Active, not recruiting

Conditions: Hernia Abdominal Wall; Hernia, Abdominal; Hernia, Ventral

Treatments: Other: Abdominal wall tension measurement

Study type: Observational

Funder types: Other

Identifiers

NCT06051578

23-857

Details and patient eligibility

About

The purpose of this study is to use a scale to learn more about the tension of the abdominal wall in hernia repairs without component separation.

1. What is the abdominal wall tension for hernias repaired without a component separation?
2. What patient factors contribute to greater abdominal wall tension?
3. Is there an association between abdominal wall tension before primary closure or bridging repair and patient outcomes?

Participants will be asked to allow their surgeon to use a tension scale to measure the tension of the abdominal wall during surgery.

Full description

This is a prospective cohort study. Patients who undergo hernia repair without component separation will have their abdominal wall tension measured using a tension scale. The scale is an investigational (experimental) device that works by attaching to surgical clamps during surgery to measure the tension on the abdominal wall. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients who are planned to undergo ventral hernia repair without component separation
2. Midline hernia

Exclusion criteria

1. Mesh excision for reasons other than mesh infection
2. Prior component separation
3. Isolated flank hernia
4. Patients under the age of 18 years
5. Pregnant patients