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Effect of Preoperative Simulator Warmup on Intraoperative Robotic Surgical Skills

Not Applicable
Completed
Conditions
Robotic Hysterectomy (Benign Indications/Early-stage Cancer)
Interventions
Other: Preoperative warm-up on simulator
Registration Number
NCT01969487
Lead Sponsor
Johns Hopkins University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Preoperative warm-up on simulatorPreoperative warm-up on simulatorTrainees perform standard practice tasks programmed into a robotic surgical simulator immediately before the surgery.
Primary Outcome Measures
NameTimeMethod
Surgical skill metricsAssessed during the surgery (scheduled immediately following warm-up/no warm-up)

Computed using surgical tool motion and/or video of procedure.

Global rating score - OSATS approachAssessed during the surgery (scheduled immediately following warm-up/no warm-up)

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.

Global rating score - GEARS approachAssessed during the surgery (scheduled immediately following warm-up/no warm-up)

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).

Secondary Outcome Measures
NameTimeMethod
Length of hospital stayWe will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.
Estimated blood lossIntraoperative
Change in hematocritPostoperative days 1, 2, and 3
Operative timeIntraoperative
Readmission or emergency room visit6 weeks after discharge from hospital (following initial admission for surgery)

Trial Locations

Locations (2)

Johns Hopkins Bayview Medical Center

🇺🇸

Baltimore, Maryland, United States

Johns Hopkins Hospital

🇺🇸

Baltimore, Maryland, United States

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