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

Last updated: April 17, 2025
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

Abdominal wall tension measurement

Clinical Study ID

NCT06051578
23-857
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who are planned to undergo ventral hernia repair without componentseparation

  2. Midline hernia

Exclusion

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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Abdominal wall tension measurement
Phase:
Study Start date:
September 08, 2023
Estimated Completion Date:
September 08, 2025

Study 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.

Connect with a study center

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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