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A Study Between Two Instrument Generations to Improve Adenoma Detection in Screening Colonoscopy

NCT03137277 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1221

Last updated 2019-06-07

No results posted yet for this study

Summary

Adenoma detection rate (ADR) is the most important parameter to measure outcome quality of (screening) colonoscopy. Since single improvements of imaging have not been able to improve ADR in many randomized studies, the present study tested the hypothesis that only multiple imaging improvements such as seen with two generation changes of colonoscopies - i.e. skipping one colonoscope generation - may be necessary before improvements in ADR can be measured.

The investigators will test this hypothesis in the present randomized tandem study in 7 private practices in Hamburg and Berlin, in a pure screening colonoscopy setting, aiming at inclusion of 1200 patients \> age of 55 years (screening colonoscopy cut-off in Germany). Exclusion criteria are symptomatic patients and colonoscopies planned for therapeutic reasons. Main outcome parameter is the ADR (rate of patients with at least one adenoma/all patients).

Conditions

  • Adenoma Detection Rate

Interventions

PROCEDURE

screening colonoscopy

Introduction and forwarding of the device up to caecum/terminal ileum. Then withdrawal and inspection of colonic wall. Biopsies and polypectomies if necessary. overall and diagnostic (only withdrawal) times being recorded separately. Polyps are documented with regards to location (caecum, ascending, transverse and descending colon, sigmoid and rectum), size (open forceps or snare for comparison) and morphology using the Paris classification (polypoid pedunculated or sessile, non-polypoid slightly elevated/flat/depressed, ulcerous) Polyps were then resected using biopsy forceps or cold snare (for polyps \< 5 mm), or conventional polypectomy according to local standards.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Thomas Rösch, Prof. Dr. · University Hospital

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-09-30
Completion
2017-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03137277 on ClinicalTrials.gov