Back to resultsLaparoscopic Versus Robot-assisted Ventral Hernia Repair: a Single Institution Randomized Controlled Trial
Primary Purpose
Ventral Hernia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
laparoscopic repair
robot-assisted repair
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernia focused on measuring robot-assisted
Eligibility Criteria
Inclusion Criteria:
- surgeon determined need for ventral hernia repair
Exclusion Criteria:
- <18 & >99 years of age
- Pregnant
- Medical indication for open repair
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
laparoscopic ventral hernia
robot-assisted ventral hernia
Arm Description
laparoscopic ventral hernia repair
robot-assisted ventral hernia repair
Outcomes
Primary Outcome Measures
Operative time
time from start to finish of procedure, procedure start and stop times as recorded by anesthesia
Secondary Outcome Measures
Post operative pain score
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03133715
Brief Title
Laparoscopic Versus Robot-assisted Ventral Hernia Repair: a Single Institution Randomized Controlled Trial
Official Title
Laparoscopic Versus Robot-assisted Ventral Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study not IRB approved.
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
robot-assisted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive either laparoscopic or robot-assisted repair of ventral hernia.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic ventral hernia
Arm Type
Active Comparator
Arm Description
laparoscopic ventral hernia repair
Arm Title
robot-assisted ventral hernia
Arm Type
Active Comparator
Arm Description
robot-assisted ventral hernia repair
Intervention Type
Procedure
Intervention Name(s)
laparoscopic repair
Intervention Description
surgical repair of ventral hernia using laparoscopic repair
Intervention Type
Procedure
Intervention Name(s)
robot-assisted repair
Intervention Description
surgical repair of ventral hernia using robot-assisted repair
Primary Outcome Measure Information:
Title
Operative time
Description
time from start to finish of procedure, procedure start and stop times as recorded by anesthesia
Time Frame
perioperative time
Secondary Outcome Measure Information:
Title
Post operative pain score
Description
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
Time Frame
until year five post-operative
Other Pre-specified Outcome Measures:
Title
Complications
Description
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.
Time Frame
From immediately post-operative until year five following surgical ventral hernia repair.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
surgeon determined need for ventral hernia repair
Exclusion Criteria:
<18 & >99 years of age
Pregnant
Medical indication for open repair
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Latzko, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
322611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Laparoscopic Versus Robot-assisted Ventral Hernia Repair: a Single Institution Randomized Controlled Trial
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