Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventral Hernia
- Sponsor
- Lucas Beffa
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Length of Stay
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.
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.
Investigators
Lucas Beffa
Assistant Professor of Surgery
The Cleveland Clinic
Eligibility 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
Outcomes
Primary Outcomes
Length of Stay
Time Frame: 30 days
Time in the hospital after the surgery
Secondary Outcomes
- Opioid consumption(30 days and one year)
- Post-operative wound complications(30 day and one year)
- Readmission rate(30 days)
- Acute pain scores(5 days after surgery)
- Hernia recurrence(30 days and one year)
- Quality of life scores using European Hernia Society (EuraHS) scale(30 day and one year)
- Other post operative complications(30 days)
- Direct cost(30 days)
- Hernia Related Specific Quality of Life Score(30 days and one year)