Operating Room Outcomes After Resident Training on a Virtual Reality Simulator

This study has been terminated.
(Principal investigator left institution.)
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00459472
First received: April 10, 2007
Last updated: April 3, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention
Gall Bladder Disease
Behavioral: laparoscopic training curriculum

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Operating Room Outcomes After Resident Training on a Virtual Reality Simulator

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Operative time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence of complications (such as bile duct injuries, bilomas, infections, bleeding) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mortality rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average days of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Training
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.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459472

Locations
United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Dennis L Fowler, MD Columbia University College of Physicians and Surgeons
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00459472     History of Changes
Other Study ID Numbers: AAAA9177
Study First Received: April 10, 2007
Last Updated: April 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
resident training
laparoscopy
virtual reality
surgical education

Additional relevant MeSH terms:
Gallbladder Diseases
Urinary Bladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2015