Gall Bladder DiseaseNCT00459472
Operating Room Outcomes After Resident Training on a Virtual Reality Simulator
A study testing laparoscopic training curriculum in people with Gall Bladder Disease, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gall Bladder Disease
- What is being tested?
- laparoscopic training curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General Surgery residents at NewYork Hospital/Columbia in PGY 1, 2, or 3.
Who cannot join
- persons who are not General Surgery residents at NewYork Hospital/Columbia in PGY 1, 2, or 3.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University College of Physicians and Surgeons
New York, New York, 10032
About this study
The purpose of this study is to compare outcomes of patients undergoing laparoscopic cholecystectomy before and after a laparoscopic training curriculum was implemented.
Read the 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.
- Conditions
- Gall Bladder Disease
- Being tested
- laparoscopic training curriculum
- Keywords
- resident training, laparoscopy, virtual reality, surgical education
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic training curriculumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Training | Other | 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. Receives: Behavioral: laparoscopic training curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Measured: 1 year
Prevalence of complications (such as bile duct injuries, bilomas, infections, bleeding)
Measured: 1 year
Mortality rate
Measured: 30 days
Secondary outcomes (1)
Average days of hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startJan 2006
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Principal investigator left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall Bladder DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis L Fowler, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459472
- Sponsor's protocol ID
- AAAA9177
- Status last verified
- Apr 2015
- First submitted
- 10 Apr 2007
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operating Room Outcomes After Resident Training on a Virtual Reality Simulator
- ClinicalTrials.gov ID
- NCT00459472
- Acronym / sponsor ID
- AAAA9177
- Conditions
- Gall Bladder Disease
- Keywords
- resident training, laparoscopy, virtual reality, surgical education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator left institution.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 12 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare outcomes of patients undergoing laparoscopic cholecystectomy before and after a laparoscopic training curriculum was implemented.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Other | Behavioral: laparoscopic training curriculumlaparoscopic 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- General Surgery residents at NewYork Hospital/Columbia in PGY 1, 2, or 3.
Key exclusion criteria (1 listed)
- persons who are not General Surgery residents at NewYork Hospital/Columbia in PGY 1, 2, or 3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic training curriculumAll 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. | Behavioural | Training |
Primary outcome
Operative time
Time frame: 1 year
Prevalence of complications (such as bile duct injuries, bilomas, infections, bleeding)
Time frame: 1 year
Mortality rate
Time frame: 30 days
1 secondary outcome
Average days of hospital stay
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Principal investigator left institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis L Fowler, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic training curriculum in people with Gall Bladder Disease, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal investigator left institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.