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

Recruiting

• Conditions: Ventral Hernia; Incisional Hernia; Parastomal Hernia

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients = 18 years of age<br><br> - Incisional or parastomal hernia with >20 cm fascial defect on pre-operative imaging<br><br> - Anticipated open bilateral transversus abdominis release with retro-muscular<br> synthetic mesh placement<br><br>Exclusion Criteria:<br><br> - Pregnant patients<br><br> - Require a Legally Authorized Representative (LAR) to sign the informed consent form

Exclusion Criteria

Not provided

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

Secondary Outcome Measures

Name	Time	Method
Correlation between intra-abdominal pressure (mmHg) to abdominal wall tension (lbs);Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to hernia defect size (cm);Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to airway pressure (cmH2O);Temporal changes in renal function (serum Creatinine)