Text Size

Case Volume and Adenoma Rate During Screening Colonoscopy

This study has been completed.
Sponsor:
Collaborator:
Interest group of Berlin private practice gastroenterologists
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00860665
First received: March 11, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 11, 2009
March 11, 2009
October 2006
March 2008   (final data collection date for primary outcome measure)
Correlation of adenoma detection rate with case volume of endoscopists [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Patient acceptance in relation to procedural factors (e.g. sedation) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Case Volume and Adenoma Rate During Screening Colonoscopy
Case Volume and Adenoma Detection Rates During Screening Colonoscopy

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
Colorectal Cancer
Not Provided
1
Observational study on consecutive persons over the age of 55 years presenting for screening colonoscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12134
March 2009
March 2008   (final data collection date for primary outcome measure)

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
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00860665
BECOP-3
No
Prof. Dr. Thomas Rösch, Department of Interdisciplinary Endoscopy, University Hospital Hamburg Eppendorf, Germany
Charite University, Berlin, Germany
Interest group of Berlin private practice gastroenterologists
Principal Investigator: Thomas Rösch, MD Department of Interdisciplinary Endoscopy, Hamburg University Eppendorf, Germany
Charite University, Berlin, Germany
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP