ROVHR: Robotic Versus Open Ventral Hernia Repair
Study Details
Study Description
Brief Summary
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Open Ventral Hernia Repair These patients will undergo open retromuscular ventral hernia repairs |
Procedure: Ventral Hernia Repair
Patients will undergo retromuscular ventral hernia repair
|
Active Comparator: Robotic Ventral Hernia Repair These patients will undergo robotic retromuscular ventral hernia repairs. |
Procedure: Ventral Hernia Repair
Patients will undergo retromuscular ventral hernia repair
|
Outcome Measures
Primary Outcome Measures
- Length of Stay [30 days]
Time in the hospital after the surgery
Secondary Outcome Measures
- Post-operative wound complications [30 day and one year]
any abnormal wound healing
- Other post operative complications [30 days]
Heart attacks, acute kidney injury, admissions to ICU, respiratory failure
- Readmission rate [30 days]
Readmission to the hospital within 30 days of the surgery
- Opioid consumption [30 days and one year]
Opioid prescribed and consumed
- Acute pain scores [5 days after surgery]
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
- Hernia Related Specific Quality of Life Score [30 days and one year]
Score of 0-100 with lower scores indicating worse quality of life
- Direct cost [30 days]
Cost to the hospital
- Hernia recurrence [30 days and one year]
Hernia recurrence
- Quality of life scores using European Hernia Society (EuraHS) scale [30 day and one year]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years and older
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7 cm to 15 cm wide hernia midline defects
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BMI less than or equal to 45
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Patient deemed both an open and robotic candidate by operating surgeon
Exclusion Criteria:
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17 years old or younger
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prisoners
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pregnant patients
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Emergent patients
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BMI greater than 45
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Hernia defects less than 7 cm or greater than 15 cm in width
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Lucas Beffa
Investigators
- Principal Investigator: Lucas Beffa, MD, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-591