Back to resultsLaparoscopic Versus Robot-assisted Inguinal Hernia Repair: A Single Institution Randomized Controlled Trial
Primary Purpose
Hernia, Inguinal
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Withdrawn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 Hernia, Inguinal focused on measuring robot-assisted
Eligibility Criteria
Inclusion Criteria:
- surgeon determined need for inguinal hernia repair
Exclusion Criteria:
- < 18 years of age
- > 99 years of age
- 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
robot-assisted
Arm Description
laparoscopic inguinal hernia repair
robot-assisted inguinal 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
Postoperative 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, one and five years postoperatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03133533
Brief Title
Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: A Single Institution Randomized Controlled Trial
Official Title
Laparoscopic Versus Robot-assisted Inguinal 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Withdrawn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
PI on an extended leave of absence.
Study Start Date
May 2018 (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 laparoscopic and robot assisted inguinal hernia repair.
Detailed Description
Inguinal 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
Hernia, Inguinal
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 inguinal hernia.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic
Arm Type
Active Comparator
Arm Description
laparoscopic inguinal hernia repair
Arm Title
robot-assisted
Arm Type
Active Comparator
Arm Description
robot-assisted inguinal hernia repair
Intervention Type
Procedure
Intervention Name(s)
laparoscopic repair
Intervention Description
Surgical inguinal hernia repair using laparoscopic approach.
Intervention Type
Procedure
Intervention Name(s)
robot-assisted repair
Intervention Description
Surgical inguinal hernia repair using robot-assisted approach.
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
Immediate perioperative time
Secondary Outcome Measure Information:
Title
Postoperative 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, one and five years postoperatively.
Time Frame
Until 5 year postoperative
Other Pre-specified Outcome Measures:
Title
Complications
Description
Postoperative 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 inguinal 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 inguinal hernia repair
Exclusion Criteria:
< 18 years of age
> 99 years of age
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
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: A Single Institution Randomized Controlled Trial
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