Effect of Preoperative Simulator Warmup on Intraoperative Robotic Surgical Skills

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

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.

Study Overview

• Status: Completed
• Conditions: Robotic Hysterectomy (Benign Indications/Early-stage Cancer)
• Intervention / Treatment: Other: Preoperative warm-up on simulator

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Grace CC Chen, M.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: September 25, 2013
• First Submitted That Met QC Criteria: October 24, 2013
• First Posted (Estimate): October 25, 2013

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: NA_00074621; WU_00074621 (Other Identifier: Other)