Clinical trial NCT01969487: Effect of Preoperative Simulator Warmup on Intraoperative Robotic Surgical Skills
Official title: Effect of Preoperative Warmup on a Simulator by Trainee Surgeons on Intraoperative Robotic Surgical Skill and Postoperative Patient Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Robotic Hysterectomy (Benign Indications/Early-stage Cancer)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Global rating score - GEARS approach
timeFrame: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
measure: Global rating score - OSATS approach
timeFrame: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
measure: Surgical skill metrics
timeFrame: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Secondary outcomes:
measure: Operative time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Length of hospital stay
timeFrame: We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.
measure: Change in hematocrit
timeFrame: Postoperative days 1, 2, and 3
measure: Readmission or emergency room visit
timeFrame: 6 weeks after discharge from hospital (following initial admission for surgery)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Grace CC Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: