TerminatedNot Applicable

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

Stopped: Interoperability issue between necessary devices.

United States2 participantsStarted 2024-08-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Correlation between intra-abdominal pressure (mmHg) and rate of post-operative complications

Timeframe: 1 year

Trial details

NCT IDNCT06575166

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-12

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