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

Recruiting

• Conditions: Parastomal Hernia; Ventral Hernia; Incisional Hernia

• Registration Number: NCT06575166
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-16
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-25
• Last Update Submitted: 2024-08-25
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-08-16
• Study Completion: 2025-08-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation between intra-abdominal pressure (mmHg) to abdominal wall tension (lbs)	1 year	Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Abdominal wall tension measured using tensiometer in pounds (lbs)
Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to hernia defect size (cm)	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)
Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to airway pressure (cmH2O)	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
Temporal changes in renal function (serum Creatinine)	1 year	Creatinine reported on routine laboratory blood work (comprehensive metabolic panel) measured over time

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States