NCT Number: NCT01969487
Effect of Preoperative Simulator Warmup on Intraoperative Robotic Surgical Skills
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.
Looking for future studies?
Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Global rating score - GEARS approach
Time frame: Assessed 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).
-
Global rating score - OSATS approach
Time frame: Assessed 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.
-
Surgical skill metrics
Time frame: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Computed using surgical tool motion and/or video of procedure.
Secondary outcomes
-
Operative time
Time frame: Intraoperative
-
Estimated blood loss
Time frame: Intraoperative
-
Length of hospital stay
Time frame: We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.
-
Change in hematocrit
Time frame: Postoperative days 1, 2, and 3
-
Readmission or emergency room visit
Time frame: 6 weeks after discharge from hospital (following initial admission for surgery)
Sponsors and collaborators
Lead sponsor
Johns Hopkins University
Other
Registry information
Official study title
Effect of Preoperative Warmup on a Simulator by Trainee Surgeons on Intraoperative Robotic Surgical Skill and Postoperative Patient Outcomes
Important dates
- Study start
- 2012
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Oct 25, 2013
- Registry last updated
- Nov 12, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
SMLI With Hispanic Cancer Survivors and Caregivers
NCT05364372
Behavior, Cancer
Tucson, Arizona, United States
View Trial DetailsClinical and Economic Impact of Herpes Zoster in Cancer Patients
NCT06207487
DNA Virus Infections, Herpes Zoster
São Paulo, Brazil
View Trial DetailsNeuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases
NCT01445483
Brain Diseases, Brain Metastasis
Bethesda, Maryland, United States
View Trial DetailsDiabetes Prevention Program Outcomes Study
NCT00038727
Body Weight, CVD
Rockville, Maryland, United States
View Trial Details