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This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair. This is a superiority trial with a primary outcome of length of stay in the hospital, theorizing that robotic retromuscular ventral hernia repairs are superior to open ventral hernia repairs by reducing length of stay by 24 hours. Patients will be blinded to the intervention, groups will be in parallel, and the primary outcome (when the patient is discharged) will be determined by a blinded assessor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Ventral Hernia Repair | Active Comparator | These patients will undergo open retromuscular ventral hernia repairs |
|
| Robotic Ventral Hernia Repair | Active Comparator | These patients will undergo robotic retromuscular ventral hernia repairs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventral Hernia Repair | Procedure | Patients will undergo retromuscular ventral hernia repair |
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| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Time in the hospital after the surgery | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative wound complications | any abnormal wound healing | 30 day and one year |
| Other post operative complications | Heart attacks, acute kidney injury, admissions to ICU, respiratory failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucas Beffa, MD | Contact | 216-445-5975 | beffal@ccf.org | |
| Alvaro Carvalho | Contact | Carvala3@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Lucas Beffa, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Health | Recruiting | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40035894 | Derived | Carvalho AC, Woo KP, Ellis RC, Tu C, Miller BT, Prabhu AS, Rosen MJ, Krpata DM, Petro CC, Beffa LR. Robotic versus open ventral hernia repair (ROVHR): a randomized controlled trial protocol. Hernia. 2025 Mar 4;29(1):109. doi: 10.1007/s10029-025-03299-7. |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Patients will be blinded to the intervention. The primary outcome will be determined by a surgeon other than the operating surgeon who is blinded to the intervention. Patients will also receive the same dressings over their wounds and an abdominal binder will be placed over the abdomen in attempts to limit the unblinding of the patient.
| 30 days |
| Readmission rate | Readmission to the hospital within 30 days of the surgery | 30 days |
| Opioid consumption | Opioid prescribed and consumed | 30 days and one year |
| Acute pain scores | Numeric Rating Scale-11 pain scores daily, 0-10 with 0 being no pain and 10 being the worst pain for first five days after surgery | 5 days after surgery |
| Hernia Related Specific Quality of Life Score | Score of 0-100 with lower scores indicating worse quality of life | 30 days and one year |
| Direct cost | Cost to the hospital | 30 days |
| Hernia recurrence | Hernia recurrence | 30 days and one year |
| Quality of life scores using European Hernia Society (EuraHS) scale | EuraHS is a hernia specific quality of life scale with three domains: pain, restrictions of activity, and cosmesis. 0-30 with higher scores indicating a worse quality of life. | 30 day and one year |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Prisma Health Greenville Memorial Hospital | Recruiting | Greenville | South Carolina | 29605 | United States |
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| University of Tennessee Medical Center, Knoxville | Recruiting | Knoxville | Tennessee | 37920 | United States |
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