Comparing robotic and open methods for ventral hernia repair
Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial
NA · The Cleveland Clinic · NCT05472987
This study is testing if robotic surgery for ventral hernia repair can help patients leave the hospital a day earlier compared to traditional open surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 4 sites (Gainesville, Florida and 3 other locations) |
| Trial ID | NCT05472987 on ClinicalTrials.gov |
What this trial studies
This randomized trial compares the effectiveness of robotic retromuscular ventral hernia repair to traditional open retromuscular ventral hernia repair. The primary goal is to determine if the robotic approach can reduce the length of hospital stay by 24 hours. Patients will be blinded to the type of intervention they receive, and the assessment of when they can be discharged will be conducted by a blinded evaluator. The study aims to provide insights into the benefits of robotic surgery in hernia repair.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with midline ventral hernia defects between 7 cm and 15 cm and a BMI of 45 or less.
Not a fit: Patients who are younger than 18, have a BMI greater than 45, or have hernia defects outside the specified size range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to shorter hospital stays for patients undergoing ventral hernia repair.
How similar studies have performed: Other studies have shown promising results with robotic surgery in various surgical fields, suggesting potential success for this approach in hernia repair.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and older * 7 cm to 15 cm wide hernia midline defects * BMI less than or equal to 45 * Patient deemed both an open and robotic candidate by operating surgeon Exclusion Criteria: * 17 years old or younger * prisoners * pregnant patients * Emergent patients * BMI greater than 45 * Hernia defects less than 7 cm or greater than 15 cm in width
Where this trial is running
Gainesville, Florida and 3 other locations
- University of Florida Health — Gainesville, Florida, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
- Prisma Health Greenville Memorial Hospital — Greenville, South Carolina, United States (RECRUITING)
- University of Tennessee Medical Center, Knoxville — Knoxville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Lucas Beffa, MD — The Cleveland Clinic
- Study coordinator: Lucas Beffa, MD
- Email: beffal@ccf.org
- Phone: 216-445-5975
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, Robotic, Hernia, Ventral hernia, Open hernia, Mesh