NCT00860665

Brief Summary

Screening colonoscopy has been established as the most effective means of colorectal cancer prevention. This is based on the fact that colonoscopy detects and removes colonic polyps (adenomas) which are known to progress to cancer if left untreated. The present study examines the question whether case volume (i.e., the number of colonoscopies performed per year) correlates with colonoscopy quality, i.e., adenoma detection rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12,134

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Typical duration 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

October 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

1.4 years

First QC Date

March 11, 2009

Last Update Submit

March 11, 2009

Conditions

Keywords

colorectal cancerpreventioncolonoscopyscreeningquality assessmentcolorectal cancer prevention

Outcome Measures

Primary Outcomes (1)

  • Correlation of adenoma detection rate with case volume of endoscopists

    18 months

Secondary Outcomes (1)

  • Patient acceptance in relation to procedural factors (e.g. sedation)

    18 months

Study Arms (1)

1

Observational study on consecutive persons over the age of 55 years presenting for screening colonoscopy

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In Germany screening colonoscopy is reimbursed over the age of 55 years. All persons willing to undergo screening colonsocopy without contraindications are asked for consent to be included

You may qualify if:

  • all persons willing and able to undergo screening colonoscopy over the age of 55 years

You may not qualify if:

  • any condition not compatible with the definition of screening colonoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Medical University Berlin Campus Virchow

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (3)

  • Adler A, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Keining C, Stange G, Wiedenmann B, Gauger U, Altenhofen L, Rosch T. Data quality of the German screening colonoscopy registry. Endoscopy. 2013 Oct;45(10):813-8. doi: 10.1055/s-0033-1344583. Epub 2013 Sep 9.

  • Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Gerber K, Stange G, Roll S, Gauger U, Wiedenmann B, Altenhofen L, Rosch T. Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3). Gut. 2013 Feb;62(2):236-41. doi: 10.1136/gutjnl-2011-300167. Epub 2012 Mar 22.

  • Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Thomas Rösch, MD

    Department of Interdisciplinary Endoscopy, Hamburg University Eppendorf, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

October 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2009

Last Updated

March 12, 2009

Record last verified: 2009-03

Locations