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

November 25, 2025 updated by: Benjamin T. Miller, The Cleveland Clinic

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of 50 patients who have been evaluated by a surgeon and will undergo a hernia repair without component separation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal wall tension in patients hernia repair without component separation
Time Frame: 2 year
The abdominal wall tension prior to closure will be measured
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient factors that contribute to greater abdominal wall tension
Time Frame: 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 year
Association between abdominal wall tension and patient outcomes
Time Frame: 2 year
Abdominal wall tension will be determined and patient outcomes will be analyzed including complications, wound morbidity, recurrence
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Actual)

May 22, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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