Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair

NCT04353687 | Active Not Recruiting FDA Device

• 1 other identifier: ISI-HLC-2019
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in cognitive and mental workload (SURG-TLX)

  With one hour following surgery (every 5th case ± 1 case)

• Change of surgeon efficiency

  Assessed intraoperatively (all cases)

• Conversion to Open

  Intraoperative

Study Arms (2)

Cohort 1 Open Surgeons

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

Device: Robotic-assisted inguinal hernia repair

Cohort 2 Laparoscopic Surgeons

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

Device: Robotic-assisted inguinal hernia repair

Interventions

Robotic-assisted inguinal hernia repair 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 1 Open Surgeons; Cohort 2 Laparoscopic Surgeons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Riverside Hospital

Newport News, Virginia, 23601, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 20, 2020
• Study Start: March 17, 2020
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)