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

Hernia, Ventral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051578
• Other study ID #: 23-857
• Status: Recruiting
• Start date: September 8, 2023
• Est. completion date: September 8, 2025

Study information

• Verified date: February 2024
• Source: The Cleveland Clinic
• Contact: Benjamin Miller, MD
• Phone: 2164068573
• Email: millerb35[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 8, 2025
• Est. primary completion date: September 8, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia Abdominal Wall
• Hernia, Abdominal
• Hernia, Ventral
• Internal Hernia

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal wall tension in patients hernia repair without component separation	The abdominal wall tension prior to closure will be measured	2 year
Secondary	Patient factors that contribute to greater abdominal wall tension	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.	2 year
Secondary	Association between abdominal wall tension and patient outcomes	Abdominal wall tension will be determined and patient outcomes will be analyzed including complications, wound morbidity, recurrence	2 year