Effect of Preoperative Simulator Warmup on Intraoperative Robotic Surgical Skills

Study Overview
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Brief Summary
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Surgical residents and fellows acquire operative knowledge and skills by assisting attending surgeons in the operating room. Previous research has shown that practising technical skills prior to operating on patients can improve how skillfully laparoscopic surgery can be performed. Although an increasingly large number of patients are undergoing robotic hysterectomy and other robotic surgical procedures, little is known on how to ensure patient safety and treatment effectiveness when trainee surgeons participate in the operating room. Our study aims to determine the impact of immediate preoperative warm-up on a robotic surgery simulator by gynecologic surgical trainees on their intraoperative performance and on patient outcomes. The investigators are randomly assigning gynecologic surgical trainees at a major academic medical center to either warm-up immediately before surgery on a robotic surgery simulator or to not warm-up. The attending surgeon supervising the trainee in the operating room is unaware of whether the trainee was assigned to warm-up or no warm-up. The investigators will compare standard robotic surgical skills assessments of the trainees by the supervising attending surgeons and patient outcomes in the two groups.

Official Title
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Effect of Preoperative Warmup on a Simulator by Trainee Surgeons on Intraoperative Robotic Surgical Skill and Postoperative Patient Outcomes

Conditions
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Robotic Hysterectomy (Benign Indications/Early-stage Cancer)

Intervention / Treatment
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* Other: Preoperative warm-up on simulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment in the graduate (residency and fellowships) gynecology training program at the study institution; Participation as assistant surgeon in a robotic hysterectomy for benign indications for early stage uterine or cervical cancer. Exclusion Criteria: Participation as assistant surgeon in a non-robotic hysterectomy or robotic hysterectomy for gynecologic cancer that has spread beyond the uterus based on preoperative imaging and biopsy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative warm-up on simulator<br>Trainees perform standard practice tasks programmed into a robotic surgical simulator immediately before the surgery. | Other: Preoperative warm-up on simulator<br> <br> |
| No Intervention: No preoperative warm-up<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global rating score - GEARS approach | Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure. Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills (OSATS) and the Global Evaluative Assessment of Robotic Surgery (GEARS). | Assessed during the surgery (scheduled immediately following warm-up/no warm-up) | 
| Global rating score - OSATS approach | Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure. Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills and the Global Evaluative Assessment of Robotic Surgery. | Assessed during the surgery (scheduled immediately following warm-up/no warm-up) | 
| Surgical skill metrics | Computed using surgical tool motion and/or video of procedure. | Assessed during the surgery (scheduled immediately following warm-up/no warm-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | Intraoperative | 
| Estimated blood loss |  | Intraoperative | 
| Length of hospital stay |  | We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days. | 
| Change in hematocrit |  | Postoperative days 1, 2, and 3 | 
| Readmission or emergency room visit |  | 6 weeks after discharge from hospital (following initial admission for surgery) |