Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-17

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hernia, Inguinal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1 Open Surgeons

Primarily open inguinal hernia surgeon with no or limited previous robotic-assisted experience.

Robotic-assisted inguinal hernia repair

Intervention Type DEVICE

Each surgeon will perform the robotic-assisted inguinal hernia procedure per their standard practice. Surgeon subjects will consent to prospectively provide selected procedure and case data.

Cohort 2 Laparoscopic Surgeons

Primarily laparoscopic inguinal hernia surgeon with no or limited previous robotic-assisted experience.

Robotic-assisted inguinal hernia repair

Intervention Type DEVICE

Each surgeon will perform the robotic-assisted inguinal hernia procedure per their standard practice. Surgeon subjects will consent to prospectively provide selected procedure and case data.

Interventions

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Robotic-assisted inguinal hernia repair

Each surgeon will perform the robotic-assisted inguinal hernia procedure per their standard practice. Surgeon subjects will consent to prospectively provide selected procedure and case data.

Intervention Type DEVICE

Eligibility Criteria

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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