Laparoscopic Versus Robot-assisted Ventral Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Florida
- Locations
- 1
- Primary Endpoint
- Operative time
Study Overview
Brief Summary
Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery.
Detailed Description
Ventral hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •surgeon determined need for ventral hernia repair
Exclusion Criteria
- •<18 & >99 years of age
- •Medical indication for open repair
Arms & Interventions
laparoscopic ventral hernia
laparoscopic ventral hernia repair
Intervention: laparoscopic repair (Procedure)
robot-assisted ventral hernia
robot-assisted ventral hernia repair
Intervention: robot-assisted repair (Procedure)
Outcomes
Primary Outcomes
Operative time
Time Frame: perioperative time
time from start to finish of procedure, procedure start and stop times as recorded by anesthesia
Secondary Outcomes
- Post operative pain score(until year five post-operative)