Clinical trial NCT04353687: Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair
Official title: PROGRESS: A PROspective Evaluation of the Early surGeon expeRiencE With Robotic-aSSisted (RA) Inguinal Hernia Repair (IHR)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hernia, Inguinal
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2020-04-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of surgeon efficiency
timeFrame: Assessed intraoperatively (all cases)
measure: Change of surgeon proficiency/performance
timeFrame: Within one month following surgery (every 12th case ± 2 cases)
Secondary outcomes:
Other outcomes:
measure: Change in cognitive and mental workload (SURG-TLX)
timeFrame: With one hour following surgery (every 5th case ± 1 case)
measure: Change of surgeon efficiency
timeFrame: Assessed intraoperatively (all cases)
measure: Conversion to Open
timeFrame: Intraoperative
measure: Number of Complications
timeFrame: Intraoperative and 30 days following discharge from hospital
measure: Length of hospital stay (LOS)
timeFrame: Arrival of the patient in the operating room to the time of patient discharge, up to an approximate of one week
Locations:
city: Newport News
country: United States
facility: Riverside Hospital
state: Virginia
Study officials:
References: