Hernia, Inguinal
Conditions
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.
Interventions
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.
Sponsors
Intuitive Surgical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of surgeon efficiency | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Conversion to Open | Intraoperative | Incidence of conversions of the robotic-assisted procedure |
| Change in cognitive and mental workload (SURG-TLX) | With one hour following surgery (every 5th case ± 1 case) | Change in cognitive and mental workload as assessed by the Surgery Task Load Index (SURG-TLX) |
| Length of hospital stay (LOS) | Arrival of the patient in the operating room to the time of patient discharge, up to an approximate of one week | The length of patient admission to the hospital |
| Number of Complications | Intraoperative and 30 days following discharge from hospital | Intraoperative and post-operative complications related to the inguinal hernia repair |
| Change of surgeon efficiency | Assessed intraoperatively (all cases) | Change of console time, docking time, and operative room time through the assessment of intraoperative tasks |
Countries
United States
Outcome results
None listed