Skip to main content
OpenTrials
Completed

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.

Completed

Looking for future studies?

Notify Me

Key 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

Loading trial locations.

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

Preoperative warm-up on simulator

Other

Primary outcomes

  1. 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).

  2. 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.

  3. 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

  1. Operative time

    Time frame: Intraoperative

  2. Estimated blood loss

    Time frame: Intraoperative

  3. 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.

  4. Change in hematocrit

    Time frame: Postoperative days 1, 2, and 3

  5. 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.

Published trials that share one or more normalized conditions with this study.