Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Device: Robotic-assisted inguinal hernia repair

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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Riverside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The intended study population will be compromised of general surgeons. All surgeons will be qualified general surgeons by training and experienced in performing open or laparoscopic inguinal hernia repair and will be transitioning to robotic-assisted inguinal hernia repair. All surgeons will have zero or minimal experience with robotic-assisted inguinal hernia repair.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive and mental workload (SURG-TLX)	Change in cognitive and mental workload as assessed by the Surgery Task Load Index (SURG-TLX)	With one hour following surgery (every 5th case ± 1 case)
Change of surgeon efficiency	Change of console time, docking time, and operative room time through the assessment of intraoperative tasks	Assessed intraoperatively (all cases)
Conversion to Open	Incidence of conversions of the robotic-assisted procedure	Intraoperative
Number of Complications	Intraoperative and post-operative complications related to the inguinal hernia repair	Intraoperative and 30 days following discharge from hospital
Length of hospital stay (LOS)	The length of patient admission to the hospital	Arrival of the patient in the operating room to the time of patient discharge, up to an approximate of one week

Collaborators and Investigators

• Sponsor: Intuitive Surgical

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2020
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: ISI-HLC-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes