CompletedNot Applicable

Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair

United States1,258 participantsStarted 2016-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Number of complications observed intraoperatively through 30-days

Timeframe: Intraoperative through 30-days follow-up

Trial details

NCT IDNCT02684448

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Hernia, Inguinal trials