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Sponsors and Collaborators: |
Charite University, Berlin, Germany Interest group of Berlin private practice gastroenterologists |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00860665 |
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 |
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Colorectal Cancer |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Case Volume and Adenoma Detection Rates During Screening Colonoscopy |
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 |
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1
Observational study on consecutive persons over the age of 55 years presenting for screening colonoscopy
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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:
Secondary outcome parameters:
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.
Ages Eligible for Study: | 55 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Charité Medical University Berlin Campus Virchow | |
Berlin, Germany, 13353 |
Principal Investigator: | Thomas Rösch, MD | Department of Interdisciplinary Endoscopy, Hamburg University Eppendorf, Germany |
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 |
colorectal cancer prevention colonoscopy |
screening quality assessment colorectal cancer prevention |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Adenoma Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |