Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • Device: 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.

Arms, Groups and Cohorts

  • Cohort 1 Open Surgeons
    • Primarily open inguinal hernia surgeon with no or limited previous robotic-assisted experience.
  • Cohort 2 Laparoscopic Surgeons
    • Primarily laparoscopic inguinal hernia surgeon with no or limited previous robotic-assisted experience.

Clinical Trial Outcome Measures

Primary Measures

  • Change of surgeon efficiency
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Intuitive Surgical
  • Provider of Information About this Clinical Study
    • Sponsor

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