Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 9
- Primary Endpoint
- Length of Stay
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Open Ventral Hernia Repair
These patients will undergo open retromuscular ventral hernia repairs
Intervention: Ventral Hernia Repair (Procedure)
Robotic Ventral Hernia Repair
These patients will undergo robotic retromuscular ventral hernia repairs.
Intervention: Ventral Hernia Repair (Procedure)
Outcomes
Primary Outcomes
Length of Stay
Time Frame: 30 days
Time in the hospital after the surgery
Secondary Outcomes
- Post-operative wound complications(30 day and one year)
- Readmission rate(30 days)
- Hernia Related Specific Quality of Life Score(30 days and one year)
- Quality of life scores using European Hernia Society (EuraHS) scale(30 day and one year)
- Opioid consumption(30 days and one year)
- Acute pain scores(5 days after surgery)
- Hernia recurrence(30 days and one year)
- Other post operative complications(30 days)
- Direct cost(30 days)
Investigators
Lucas Beffa
Assistant Professor of Surgery
The Cleveland Clinic