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Operating Room Outcomes After Resident Training on a Virtual Reality Simulator

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ClinicalTrials.gov Identifier: NCT00459472
Recruitment Status : Terminated (Principal investigator left institution.)
First Posted : April 12, 2007
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
Columbia University

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

Condition or disease Intervention/treatment Phase
Gall Bladder Disease Behavioral: laparoscopic training curriculum Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Operating Room Outcomes After Resident Training on a Virtual Reality Simulator
Study Start Date : January 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Diseases
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Operative time [ Time Frame: 1 year ]
  2. Prevalence of complications (such as bile duct injuries, bilomas, infections, bleeding) [ Time Frame: 1 year ]
  3. Mortality rate [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Average days of hospital stay [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00459472     History of Changes
Other Study ID Numbers: AAAA9177
First Posted: April 12, 2007    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015

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

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