Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair

Active, not recruiting

• Conditions: Hernia, Inguinal
• Interventions: Device: Robotic-assisted inguinal hernia repair

• Registration Number: NCT04353687
• Lead Sponsor: Intuitive Surgical

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-03-17
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of surgeon efficiency	Assessed intraoperatively (all cases)	Change of skin to skin procedure time, dissection time, time to establish critical view of the myopectineal orifice (MPO), and mesh fixation time through the assessment of intraoperative tasks
Change of surgeon proficiency/performance	Within one month following surgery (every 12th case ± 2 cases)	Change of technical proficiency scores and Global Evaluative Assessment of Robotic Skills (GEARS) scores cases as assessed by independent video review.

Trial Locations

Locations (1)

Riverside Hospital; 🇺🇸 Newport News, Virginia, United States