NCT00459472

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

April 10, 2007

Last Update Submit

April 3, 2015

Conditions

Gall Bladder Disease

Keywords

resident traininglaparoscopyvirtual realitysurgical education

Outcome Measures

Primary Outcomes (3)

  • Operative time

    1 year

  • Prevalence of complications (such as bile duct injuries, bilomas, infections, bleeding)

    1 year

  • Mortality rate

    30 days

Secondary Outcomes (1)

  • Average days of hospital stay

    30 days

Study Arms (1)

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.

Behavioral: laparoscopic training curriculum

Interventions

laparoscopic training curriculumBEHAVIORAL

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.

Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Dennis L Fowler, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 12, 2007

Study Start

January 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

US(1)