Effect of Preoperative Simulator Warmup on Intraoperative Robotic Surgical Skills

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT01969487

Run by

Johns Hopkins University

People needed

22

Starts

2012-12-01

Expected to finish

2014-06-01

Last updated by the study team

2020-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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