Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair

Study Overview
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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.

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.

Official Title
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PROGRESS: A PROspective Evaluation of the Early surGeon expeRiencE With Robotic-aSSisted (RA) Inguinal Hernia Repair (IHR)

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Device: Robotic-assisted inguinal hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent by adult surgeon subject Practicing general surgeon with no or limited robotic assisted experience Full access to the da Vinci surgical system at hospital and ability to perform robotic cases as needed 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 Open Surgeons<br>Primarily open inguinal hernia surgeon with no or limited previous robotic-assisted experience. | Device: Robotic-assisted inguinal hernia repair<br>* 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.<br>|
| Cohort 2 Laparoscopic Surgeons<br>Primarily laparoscopic inguinal hernia surgeon with no or limited previous robotic-assisted experience. | Device: Robotic-assisted inguinal hernia repair<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of surgeon efficiency | 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 | Assessed intraoperatively (all cases) | 
| Change of surgeon proficiency/performance | Change of technical proficiency scores and Global Evaluative Assessment of Robotic Skills (GEARS) scores cases as assessed by independent video review. | Within one month following surgery (every 12th case ± 2 cases) |