Operating Room Outcomes After Resident Training on a Virtual Reality Simulator

Gall Bladder Disease Clinical Trial

Official title:

Operating Room Outcomes After Resident Training on a Virtual Reality Simulator

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00459472
• Other study ID #: AAAA9177
• Status: Terminated
• Phase: N/A
• First received: April 10, 2007
• Last updated: April 3, 2015
• Start date: January 2006
• Est. completion date: August 2008

Study information

• Verified date: April 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare outcomes of patients undergoing laparoscopic cholecystectomy before and after a laparoscopic training curriculum was implemented.

Description:

All general surgery interns and PGY-2's AND PGY 3's will be enrolled in a laparoscopic surgery training curriculum that includes practicing surgical skills on a laparoscopic simulator. The PI has constructed an examination on the simulator that will document a significant level of laparoscopic skill. Each general surgery intern, second, AND THIRD year general surgery resident will be required to pass this examination on the simulator prior to being given more responsibility during cases of laparoscopic cholecystectomy. Specifically, interns, second, AND THIRD year residents must pass the examination on the simulator before they are allowed to function as primary surgeon in a supervised setting during laparoscopic cholecystectomy. These interns, PGY-2's, AND PGY 3'S would then be allowed to function as primary surgeon under the supervision of an attending surgery for laparoscopic cholecystectomy cases. The outcomes of these cases would be compared to a matched group of laparoscopic cholecystectomy cases performed by second year general surgery residents in the same supervised environment (but without having trained on the simulator) one year prior.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• General Surgery residents at NewYork Hospital/Columbia in PGY 1, 2, or 3.

Exclusion Criteria:

• persons who are not General Surgery residents at NewYork Hospital/Columbia in PGY 1, 2, or 3.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gall Bladder Disease
• Gallbladder Diseases
• Urinary Bladder Diseases

Intervention

Behavioral:
• laparoscopic training curriculum
All general surgery interns and PGY-2-5's already participate in a surgery training curriculum that includes lectures, surgery, laparoscopic training, attending surgeons evaluating performance of residents at the end of surgical procedures, written tests, and skills tests.

Locations

Country	Name	City	State
United States	Columbia University College of Physicians and Surgeons	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time		1 year	No
Primary	Prevalence of complications (such as bile duct injuries, bilomas, infections, bleeding)		1 year	No
Primary	Mortality rate		30 days	No
Secondary	Average days of hospital stay		30 days	No