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Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair

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Intuitive Surgical

Status

Active, not recruiting

Conditions

Hernia, Inguinal

Treatments

Device: Robotic-assisted inguinal hernia repair

Study type

Observational

Funder types

Industry

Identifiers

NCT04353687
ISI-HLC-2019

Details and patient eligibility

About

The primary objective of this study is to evaluate the progression of surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair throughout their learning curve.

Full description

This is a prospective, multi-center, observational pilot study evaluating surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair. The study will focus on surgeon intraoperative efficiency and technical performance outcomes as well as conversions, intraoperative complications, and mental and cognitive workload. Surgeon subjects will be assessed for technical proficiency through a study specific technical proficiency form and the GEARS scale by independent surgeons.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Signed and dated informed consent by adult surgeon subject
  2. Practicing general surgeon with no or limited robotic assisted experience
  3. Full access to the da Vinci surgical system at hospital and ability to perform robotic cases as needed
  4. Willingness to participate in all aspects of the study

Exclusion criteria

  1. Condition(s) that, in the opinion of the investigator, may prevent completion of the study or protocol requirements

Trial design

6 participants in 2 patient groups

Cohort 1 Open Surgeons
Description:
Primarily open inguinal hernia surgeon with no or limited previous robotic-assisted experience.
Treatment:
Device: Robotic-assisted inguinal hernia repair
Cohort 2 Laparoscopic Surgeons
Description:
Primarily laparoscopic inguinal hernia surgeon with no or limited previous robotic-assisted experience.
Treatment:
Device: Robotic-assisted inguinal hernia repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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