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Clinical Trials/NCT00860665
NCT00860665
Completed
Not Applicable

Case Volume and Adenoma Detection Rates During Screening Colonoscopy

Charite University, Berlin, Germany1 site in 1 country12,134 target enrollmentOctober 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Charite University, Berlin, Germany
Enrollment
12134
Locations
1
Primary Endpoint
Correlation of adenoma detection rate with case volume of endoscopists
Status
Completed
Last Updated
17 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
March 2009
Last Updated
17 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Correlation of adenoma detection rate with case volume of endoscopists

Time Frame: 18 months

Secondary Outcomes

  • Patient acceptance in relation to procedural factors (e.g. sedation)(18 months)

Study Sites (1)

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