Examining how abdominal wall reconstruction affects tension and pressure in the abdomen
The Impact of Abdominal Wall Reconstruction on Abdominal Wall Tension and Intra-Abdominal Pressure
The Cleveland Clinic · NCT06575166
This study tests how fixing large hernias in the abdomen affects the tightness and pressure inside the belly for patients undergoing surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06575166 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with incisional or parastomal hernias that have a fascial defect greater than 20 cm. Participants will undergo an open bilateral transversus abdominis release with retromuscular synthetic mesh. The study aims to measure abdominal wall tension and intra-abdominal pressure using specialized sensors. By quantifying these changes, the researchers hope to explore the physiological shifts associated with abdominal wall reconstruction.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant incisional or parastomal hernias requiring surgical intervention.
Not a fit: Patients who are pregnant or require a legally authorized representative for consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing surgical techniques for hernia repair, potentially improving patient outcomes.
How similar studies have performed: While this approach is observational and may build on existing knowledge, the specific methodology of measuring tension and pressure in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Benjamin T Miller, MD — The Cleveland Clinic
- Study coordinator: Benjamin T Miller, MD
- Email: millerb35@ccf.org
- Phone: 2164068573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ventral Hernia, Incisional Hernia, Parastomal Hernia