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Completed

NCT Number: NCT00860665

Case Volume and Adenoma Rate 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité Medical University Berlin Campus Virchow

Berlin, State of Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation of adenoma detection rate with case volume of endoscopists

    Time frame: 18 months

Secondary outcomes

  1. Patient acceptance in relation to procedural factors (e.g. sedation)

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Interest group of Berlin private practice gastroenterologists

Registry information

Official study title

Case Volume and Adenoma Detection Rates During Screening Colonoscopy

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Mar 12, 2009
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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