NCT01786213

Brief Summary

Colon cancer is the second most common cause of death among cancer-related deaths in Germany. Precancerous lesions such as adenomas can be detected efficiently by colonoscopy. To provide high quality in colonoscopy several quality parameters have been postulated in the past. The adenoma detection rate (ADR) is one of those parameters. Empirical data suggest that a detection rate of 20% should be demanded. Detection rates are influenced by a multitude of circumstances such as bowel cleanness. The facts that detection rates vary between colonoscopists suggests that leaning effects may also play a role. It is not known how ADR and other quality parameters evolve while trainees improve their skills in colonoscopy. The investigators postulate that a learning curve exists. The investigators therefore plan to evaluate chronologically the findings of trainee colonoscopists. A particular performance in detecting adenomas shall be calculated in relation to the amount of examinations performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2013

Enrollment Period

11 months

First QC Date

February 5, 2013

Last Update Submit

February 5, 2014

Conditions

Adenoma Detection Rate

Keywords

adenoma detection rate, colonoscopy, trainee, learning curve

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    While numbers of investigations rise new detection rates are calculated for each colonoscopist.

    every 50 examinations

Secondary Outcomes (1)

  • Polyp detection rate

    every 50 examinations

Other Outcomes (1)

  • Amount of sedative used

    every 50 exmainations

Study Arms (10)

Colonoscopist A

Colonoscopist B

Colonoscopist C

Colonoscopist D

Colonoscopist E

Colonoscopist F

Colonoscopist G

Colonoscopist H

Colonoscopist I

Colonoscopist J

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Endoscopy Department of a university Hospital

You may qualify if:

  • colonoscopy performed at the Technical University Munich, Germany

You may not qualify if:

  • colonoscopy performed for the purpose of polypectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik und Poliklinik der Technischen Universität München

Munich, Bavaria, 81675, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histological findings are recorded

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

February 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 6, 2014

Record last verified: 2013-02

Locations

DE(1)