The Impact of Abdominal Wall Reconstruction on Abdominal Wall Tension and Intra-Abdominal Pressure

September 15, 2025 updated by: Benjamin T. Miller, The Cleveland Clinic
This is a prospective cohort study. Patients have an incisional or parastomal hernia with >20 cm fascial defect on pre-operative imaging who will undergo an anticipated open bilateral transversus abdominis release with retromuscular synthetic mesh will have their abdominal wall tension measured using a tension scale and their intra-abdominal pressure measured using a urinary catheter containing pressure sensors. The investigators aim to quantify the changes, as well as explore and describe the physiologic shifts that may be associated with these changes.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2

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

Probability Sample

Study Population

Adult patients with an incisional or parastomal hernia with a >20 cm fascial defect on pre-operative imaging who undergo an anticipated open bilateral transversus abdominis release with retro-muscular synthetic mesh placement will be included. The investigators anticipate that patients with very large defects will experience the greatest changes in abdominal wall tension and intra-abdominal pressure.

Description

Inclusion Criteria:

  • Patients ≥ 18 years of age
  • Incisional or parastomal hernia with >20 cm fascial defect on pre-operative imaging
  • Anticipated open bilateral transversus abdominis release with retro-muscular synthetic mesh placement

Exclusion Criteria:

  • Pregnant patients
  • Require a Legally Authorized Representative (LAR) to sign the informed consent form

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
Correlation between intra-abdominal pressure (mmHg) and rate of post-operative complications
Time Frame: 1 year
Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Post-operative complications measured in proportion of events
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between intra-abdominal pressure (mmHg) to abdominal wall tension (lbs)
Time Frame: 1 year
Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Abdominal wall tension measured using tensiometer in pounds (lbs)
1 year
Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to hernia defect size (cm)
Time Frame: 1 year
Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Abdominal wall tension measured using tensiometer in pounds (lbs) Hernia defect size (length and width in cm)
1 year
Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to airway pressure (cmH2O)
Time Frame: 1 year
Intra-abdominal pressure using TraumaGuard catheter in mmHg Abdominal wall tension measured using tensiometer in pounds Airway pressure measured on mechanical ventilator in cmH2O
1 year
Temporal changes in renal function (serum Creatinine)
Time Frame: 1 year
Creatinine reported on routine laboratory blood work (comprehensive metabolic panel) measured over time
1 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 T 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)

August 16, 2024

Primary Completion (Actual)

September 12, 2025

Study Completion (Actual)

September 12, 2025

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-655

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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