Clinical trial NCT00555243: Laparoscopic Simulator Training and Its Impact on Surgical Education
Official title: An Evaluation of Validated Laparoscopic Skills Simulators and the Impact on Operating Room Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Surgical Simulation
Keywords: Laparoscopic Surgical Simulation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Ochsner Health System
name: University of Alabama at Birmingham
name: The University of Texas Health Science Center, Houston
name: Uniformed Services University of the Health Sciences
name: Orlando Health, Inc.
name: Virginia Commonwealth University
First posted: 2007-11-08
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary goal of this study is to answer whether validated laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents.

Detailed description: We have designed a randomized control trial to assess the impact of a laparoscopic simulator curriculum on operating room performance amongst gynecology residents. At the beginning of the study, each resident that chooses to participate will take a multiple choice pre-test assessing his or her background knowledge of laparoscopic surgical principles. Everyone will then listen to a series of lectures / video demonstrations teaching the fundamentals of laparoscopic surgery. The final part of the orientation is to have each resident perform 5 tasks on the laparoscopic simulators (peg transfer, endoloop, pattern cutting, intracorporeal suturing, and extracorporeal suturing) while being proctored by a faculty member who is timing the task and recording any errors made. Each resident will have 2 proctored performances (pre- and post) on the simulator and it will be set up as a typical OSCE-type exam. We chose to have them perform 2 repetitions as opposed to the usual 1 (like on the MCAT, SAT, or other high stake exam) to allow for potential unfamiliarity with the simulator equipment.

The residents will then perform a laparoscopic tubal ligation with a faculty member when they begin their Benign Gynecology rotation. Each resident will subsequently be randomized either traditional teaching (no simulator) or five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab. Those randomized to simulation training can practice and perform as many repetitions necessary on the simulator to achieve proficiency. Prior to completing the rotation, the residents will perform another laparoscopic tubal ligation with a faculty member blinded to whether they randomized to simulator training to re-assess their technical skills. The resident will have another proctored examination of simulator performance on the five tasks. Finally, a videotape review by independent observers will verify precision of the surgical evaluations at the conclusion of the study.

Eligibility criteria: Inclusion Criteria:

* All Ob/Gyn residents in post-graduate years 1-4 from ACGME accredited programs

Exclusion Criteria:

* none

Primary outcomes:
measure: Whether laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents
timeFrame: Over the course of one resident rotation (4-6 weeks)
Secondary outcomes:
measure: Determine if the level of improvement is inversely related to resident level of training.
timeFrame: Over the course of one resident rotation (4-6 weeks)
measure: Calculate receiver operator curves to aid in the establishment of a "passing score" threshold on the validated laparoscopic simulators
timeFrame: Over the course of one resident rotation (4-6 weeks)
measure: Establish whether psychomotor testing predicts surgical proficiency and helps identify those who may need more intensive training over the course of their education.
timeFrame: Over the course of one resident rotation (4-6 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Department of Ob/Gyn
state: Alabama
city: Washington
country: United States
facility: Uniformed Services University of the Health Sciences
state: District of Columbia
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas at Houston Department of Ob/Gyn
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Rajiv B Gala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gala R, Orejuela F, Gerten K, Lockrow E, Kilpatrick C, Chohan L, Green C, Vaught J, Goldberg A, Schaffer J. Effect of validated skills simulation on operating room performance in obstetrics and gynecology residents: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):578-584. doi: 10.1097/AOG.0b013e318283578b.