Case Volume and Adenoma Rate During Screening Colonoscopy - Full Text View

Sponsors and Collaborators:	Charite University, Berlin, Germany Interest group of Berlin private practice gastroenterologists
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00860665

Purpose

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.

Condition
Colorectal Cancer

MedlinePlus related topics: Cancer Colonoscopy Colorectal Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Case Volume and Adenoma Detection Rates During Screening Colonoscopy

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Correlation of adenoma detection rate with case volume of endoscopists [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient acceptance in relation to procedural factors (e.g. sedation) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	12134
Study Start Date:	October 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Observational study on consecutive persons over the age of 55 years presenting for screening colonoscopy

Detailed Description:

21 private practice gastroenterologist endoscopists from Berlin performed a prospective quality assessment study including at least 10.000 screening colonoscopies. After informed consent, patients data are included (age, sex, family history, colonoscopy performance parameters and findings, therapy performed, histology of biopsies and/or polypectomies, complications (immediate and late) and patient acceptance. The latter was retrieved by patient questionnaires returned after a minimum of 2 weeks. Data were centrally collected in an anonymized way

Primary outcome parameter:

Correlation of adenoma detection rate with case volume and other confounding factors (e.g., withdrawal time)

Secondary outcome parameters:

Complications and method of assessment (immediate recording versus later questionnaire enquiry)
Quality of bowel preparation in relation to outcome Patient acceptance in relation to procedural factors (e.g., sedation)
Quality of pathology reports and histologic outcome of polypectomy

Later follow-up (after 5-10 years) of the preventive effect of colonoscopy is planned and has been part of the protocol and patient consent form.

Eligibility

Ages Eligible for Study:	55 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

any condition not compatible with the definition of screening colonoscopy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860665

Locations

Germany
Charité Medical University Berlin Campus Virchow
Berlin, Germany, 13353

Sponsors and Collaborators

Charite University, Berlin, Germany

Interest group of Berlin private practice gastroenterologists

Investigators

Principal Investigator:

Thomas Rösch, MD

Department of Interdisciplinary Endoscopy, Hamburg University Eppendorf, Germany

More Information

No publications provided

Responsible Party:	Department of Interdisciplinary Endoscopy, University Hospital Hamburg Eppendorf, Germany ( Prof. Dr. Thomas Rösch )
Study ID Numbers:	BECOP-3
Study First Received:	March 11, 2009
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00860665 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

colorectal cancer
prevention
colonoscopy

screening
quality assessment
colorectal cancer prevention

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Intestinal Diseases
Rectal Diseases
Adenoma
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009