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

Last updated: August 25, 2024
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Pentalogy Of Cantrell

Treatment

Abdominal wall tension

Intra-abdominal pressure

Clinical Study ID

NCT06575166
24-655
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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-muscularsynthetic mesh placement

Exclusion

Exclusion Criteria:

  • Pregnant patients

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

Study Design

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: Abdominal wall tension
Phase:
Study Start date:
August 16, 2024
Estimated Completion Date:
August 16, 2025

Connect with a study center

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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