Abdominal Wall Tension Following Mesh Excision

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06051578
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The purpose of this study is to use a scale to learn more about the tension of the abdominal wall before and after mesh removal. The main questions this study aims to answer are:

1. How does mesh excision affect abdominal wall tension?

2. What patient factors contribute to greater abdominal wall tension after excision?

3. Do patients who undergo mesh excision have greater abdominal wall tension than physiologic tension (0-1 lbs) at baseline and/or after mesh excision?

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

Condition or Disease	Intervention/Treatment	Phase
Mesh Excision; Mesh Infection	Other: Abdominal wall tension measurement

Detailed Description

This is a prospective cohort study. Patients who undergo mesh excision will have the tension of their abdominal wall measured prior to mesh excision and after mesh excision 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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Abdominal Wall Tension Following Mesh Excision
• Actual Study Start Date: Sep 8, 2023
• Anticipated Primary Completion Date: Sep 8, 2025
• Anticipated Study Completion Date: Sep 8, 2025

Outcome Measures

Primary Outcome Measures

1. Changes in abdominal wall tension in patients undergoing mesh excision [2 year]

   The difference between tension measurements prior to mesh excision and after mesh excision will be calculated.

Secondary Outcome Measures

1. Patient factors that contribute to greater abdominal wall tension after excision [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.

2. Comparison between abdominal wall tension before and after mesh excision to current knowledge of physiologic tension [2 year]

   Median abdominal wall tension will be determined and compared to current knowledge of physiologic tension

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients with a history of prior hernia repair with synthetic mesh in place who are planned to undergo mesh excision will be included.

Exclusion Criteria:

• Patients under the age of 18 years and pregnant patients.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Benjamin Miller, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benjamin T. Miller, Principal Investigator, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT06051578
• Other Study ID Numbers: 23-857
• First Posted: Sep 25, 2023
• Last Update Posted: Sep 25, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 25, 2023