Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04353687
• Other study ID #: ISI-HLC-2019
• Status: Active, not recruiting
• Start date: March 17, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

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.

Locations

Country	Name	City	State
United States	Riverside Hospital	Newport News	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Change of surgeon efficiency	Change of console time, docking time, and operative room time through the assessment of intraoperative tasks	Assessed intraoperatively (all cases)
Other	Conversion to Open	Incidence of conversions of the robotic-assisted procedure	Intraoperative
Other	Number of Complications	Intraoperative and post-operative complications related to the inguinal hernia repair	Intraoperative and 30 days following discharge from hospital
Other	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
Primary	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)
Primary	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)