A Study Between Two Instrument Generations to Improve Adenoma Detection in Screening Colonoscopy
NCT ID: NCT03137277
Last Updated: 2019-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1221 participants
OBSERVATIONAL
2013-11-30
2017-07-31
Brief Summary
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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).
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Detailed Description
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Patients were selected from the screening colonoscopy list (age ≥ 55 years), with further inclusion criteria being status 1 and 2 of the ASA classification. After informed consent, patients were randomized using sealed envelopes per center to one of either of the two study groups
1. 190 C group (intervention group), examination with the latest generation colonoscope (190 series CF or PCF colonoscopies, Olympus Corp, Hamburg, Germany).
2. 165 C group (control group), examination with the 160/5 generation colonoscope (Olympus Corp, Hamburg, Germany), Each patient underwent bowel preparation in accordance with local practice of the centers. Bowel cleansing quality was segmentally assessed using a modified overall "Boston Bowel Preparation Scale". Introduction and withdrawal times were measured, and times required for biopsies and polypectomies were considered separately, i.e. overall and diagnostic only withdrawal times were recorded separately.
Polyps were documented with regards to location (caecum, ascending, transverse and descending colon, sigmoid and rectum), size 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 or conventional polypectomy according to local standards. Histology of resected polyps was analyzed by local private practice specialized GI pathologists according to the Vienna classification with regards to dysplasia grade and the presence of serrated adenomas; final histologic categories were hyperplastic, adenomatous \[tubulous, villous, tubulovillous, serrated (traditional or sessile serrated)\]. Small distal rectal polyps were not systematically biopsied or resected, due to a very high likelihood to be hyperplastic.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Olympus 190
Olympus colonoscope 190 C (intervention group), screening colonoscopy examination with the latest generation colonoscope (190 series CF or PCF colonoscopies, Olympus Corp, Hamburg, Germany).
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.
Olympus 160/165
Olympus colonoscope 165 C (control group), screening colonoscopy examination with the 160/5 generation colonoscope (Olympus Corp, Hamburg, Germany),
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* status 1 and 2 of the ASA classification
* signed informed consent
Exclusion Criteria
* Known colonic disease for further evaluation (e.g. inflammatory bowel disease, polyps for resection)
* Surveillance after polypectomy or colon tumor surgery
* Anticoagulants preventing biopsy or polypectomy
* Poor general condition (ASA III or more)
* Incomplete colonoscopy planned
55 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Prof. Dr. Thomas Rösch
Clinic Director of Interdisciplinary Endoscopy Department and Clinic
Principal Investigators
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Thomas Rösch, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital
Locations
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Gemeinschaftspraxis Hohenzollerndamm
Berlin, , Germany
Gastroenterologie am Bayerischen Platz
Berlin, , Germany
Praxis Mayr / Heller
Berlin, , Germany
Dr. Alireza Aminalai
Berlin, , Germany
Dr. Jens Aschenbeck
Berlin, , Germany
Gastropraxis Eppendorferbaum
Hamburg, , Germany
Gastroenterologie-Fontanay
Hamburg, , Germany
Countries
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References
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Other Identifiers
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PV4343
Identifier Type: -
Identifier Source: org_study_id
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