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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Open Surgeons | Primarily open inguinal hernia surgeon with no or limited previous robotic-assisted experience. |
| |
| Cohort 2 Laparoscopic Surgeons | Primarily laparoscopic inguinal hernia surgeon with no or limited previous robotic-assisted experience. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
1. Condition(s) that, in the opinion of the investigator, may prevent completion of the study or protocol requirements
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Hospital | Newport News | Virginia | 23601 | United States |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |