Ventral Hernia
Conditions
Keywords
robot-assisted
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.
Interventions
PROCEDURElaparoscopic repair
surgical repair of ventral hernia using laparoscopic repair
PROCEDURErobot-assisted repair
surgical repair of ventral hernia using robot-assisted repair
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized to receive either laparoscopic or robot-assisted repair of ventral hernia.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* surgeon determined need for ventral hernia repair
Exclusion criteria
* \<18 & \>99 years of age * Pregnant * Medical indication for open repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | perioperative time | time from start to finish of procedure, procedure start and stop times as recorded by anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain score | until year five post-operative | Abdominal pain at rest and on moving (recumbent to the upright position), will be assessed using 0-10 Numeric Pain Rating Scale preoperatively (baseline), and at 24 hours, 30 days, and one year postoperatively |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications | From immediately post-operative until year five following surgical ventral hernia repair. | Post-operative 30 day complication rates will be recorded prospectively. All complications (including multiple occurrences per patient) will be recorded and graded per the Clavien-Dindo classification system. |
Countries
United States
Outcome results
None listed