Clinical trial NCT00860665: Case Volume and Adenoma Rate During Screening Colonoscopy
Official title: Case Volume and Adenoma Detection Rates During Screening Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: colorectal cancer
prevention
colonoscopy
screening
quality assessment
colorectal cancer prevention
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Interest group of Berlin private practice gastroenterologists
First posted: 2009-03-12
Enrollment: 12134
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

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

Primary outcomes:
measure: Correlation of adenoma detection rate with case volume of endoscopists
timeFrame: 18 months
Secondary outcomes:
measure: Patient acceptance in relation to procedural factors (e.g. sedation)
timeFrame: 18 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Medical University Berlin Campus Virchow
Study officials:
affiliation: Department of Interdisciplinary Endoscopy, Hamburg University Eppendorf, Germany
name: Thomas Rösch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.