Simulation Based Training in Colonoscopy | NCT02043327

Studies
Simulation Based Training in Colonoscopy

NCT02043327

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Jan 23, 2014Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Group Identification

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Jan 10, 2014

First Submission Date that Met QC Criteria

Jan 21, 2014

First Posted Date

Jan 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2014

Last Update Posted Date

Jan 23, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to create simulation-based tests with credible pass/fail-standards for two different fidelities of colonoscopy models

virtual reality simulator
physical model simulator To create pass/ fail standards for certification

Detailed Description

Twenty-five physicians (10 consultants with endoscopic experience and 15 fellows in the first year of fellowship without endoscopic experience) will be tested twice on each of the two different simulator models.

Metrics with discriminatory ability will be identified for both modalities. Reliability will be determined A pass/ fail standard will be determined and the concequences explored.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experienced in Colonoscopy		two tests on two different modalities of colonoscopy simulators
Novices in colonoscopy		Two tests on each of trw colonoscopy simulators

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metrics with discriminatory ability measuring colonoscopy competence	Each participant perform two tests on each model within the same day.	tests were carried out in one day per participant

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: For the two groups

Experienced endoscopists :

Having performed >350 colonoscopy procedures

Novice endoscopists:

First or second year of fellowship in gastroenterology Having performed less than 3 colonoscopies

Exclusion Criteria: For the two groups

Experienced endoscopists:

Prior simulator training

Novice endoscopists:

Prior simulator training

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Experienced: 10 consultants of gastroenterology with experience in Colonoscopy (>350 procedures) Novices: 15 fellows of gastroenterology with limited experience in Colonoscopy (<2 procedures)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louise Preisler, MD	Rigshospitalet, Copenhagen, University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet; CEKU		Copenhagen	Copenhagen	2100	Denmark

ID	Term
D012919	Social Behavior
D001519	Behavior