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

Recruiting

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

• Registration Number: NCT06051578
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-09-08
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-09-08
• Study Completion: 2025-09-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abdominal wall tension in patients hernia repair without component separation	2 year	The abdominal wall tension prior to closure will be measured

Secondary Outcome Measures

Name	Time	Method
Patient factors that contribute to greater abdominal wall tension	2 year	Patient demographics, comorbidities, operative history, operative details, hernia size and width and abdominal wall tension will be collected and analyzed to determine what factors contribute to abdominal wall tension.
Association between abdominal wall tension and patient outcomes	2 year	Abdominal wall tension will be determined and patient outcomes will be analyzed including complications, wound morbidity, recurrence

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States