- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00860665
Case Volume and Adenoma Rate During Screening Colonoscopy
Case Volume and Adenoma Detection Rates During Screening Colonoscopy
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 13353
- Charité Medical University Berlin Campus Virchow
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Observational study on consecutive persons over the age of 55 years presenting for screening colonoscopy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Correlation of adenoma detection rate with case volume of endoscopists
Time Frame: 18 months
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18 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Patient acceptance in relation to procedural factors (e.g. sedation)
Time Frame: 18 months
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18 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Thomas Rösch, MD, Department of Interdisciplinary Endoscopy, Hamburg University Eppendorf, Germany
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Adenoma
Other Study ID Numbers
- BECOP-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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