Clinical Trial: Case Volume and Adenoma Rate During Screening Colonoscopy
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Case Volume and Adenoma Detection Rates During Screening Colonoscopy
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 Summary:
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.
Sponsor: Charite University, Berlin, Germany
Current Primary Outcome: Correlation of adenoma detection rate with case volume of endoscopists [ Time Frame: 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient acceptance in relation to procedural factors (e.g. sedation) [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: Charite University, Berlin, Germany
Dates:
Date Received: March 11, 2009
Date Started: October 2006
Date Completion:
Last Updated: March 11, 2009
Last Verified: March 2009
