Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair
Completed
Conditions studied: Hernia, Inguinal, Hernia, Inguinal, Direct, Hernia, Inguinal, Indirect
In brief
This multi-center, retrospective data collection study will evaluate the feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone robotic-assisted inguinal hernia repair, as well as provide information about the learning curve associated with robotic-assisted (da Vinci®) inguinal hernia repair. In addition, this retrospective data collection study will evaluate the perioperative outcomes of robotic-assisted (da Vinci®) inguinal hernia repair and compare perioperative outcomes with those associated with open hernia repair by the same participating surgeon.
Key facts
- Study ID
- NCT02684448
- Run by
- Intuitive Surgical
- People needed
- 1258
- Starts
- 2016-01-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2017-03-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- all patients who have undergone inguinal hernia repair using either an open technique or a robotic-assisted (da Vinci®) approach
- Eligible subjects must have had their inguinal hernia repair completed according to the following timeframes for inclusion:
- Robotic-assisted (da Vinci®) hernia repair - all consecutive robotic cases from the initiation of robotic -assisted inguinal hernia repair at each institution until 30 days prior to the date of study initiation (IRB approval and fully executed contract).
- Open hernia repair - all consecutive open hernia repair cases from the day prior to the 1st da Vinci® inguinal hernia repair until the number of open repair cases collected is equivalent to the number of da Vinci® cases entered, or the date 5 years pre-robotic initiation is reached.
You may not qualify if…
- Subjects who have undergone robotic-assisted or open inguinal hernia repair outside of required timeframe
Where it is running
- Progressive Surgical Associates/Silver Cross Hospital — New Lenox, Illinois, United States
- Rochester General Hospital — Rochester, New York, United States
Full record on ClinicalTrials.gov
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