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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-08

Study Completion Date

2026-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hernia, Ventral Hernia, Abdominal Hernia Abdominal Wall

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Abdominal wall tension measurement

All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes