Withdrawal Time and Use of Wide-angle Endoscope to Increase the Adenoma Detection Rate of Screening Colonoscopy
NCT ID: NCT02985944
Last Updated: 2021-01-20
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
1000 participants
OBSERVATIONAL
2016-06-30
2018-12-31
Brief Summary
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Detailed Description
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Aim of the study to evaluate the impact on the adenoma detection rate either of the use of a FUSE endoscope or of interventions directed at optimizing withdrawal time.
to assess the impact of different factors in influencing the withdrawal time
Methods A prospective non-randomized observational single-center study involving consecutive outpatients, aged 18-85 yr, undergoing colonoscopy with different indications. Previous abdominal colon resection, obstruction, inadequate preparation and incomplete examination were exclusion criteria.
In a 3-month period 4 expert endoscopists will performed 500 colonoscopies either with standard endoscope or with FUSE without a dedicated withdrawal time protocol. Colonoscopy withdrawal times will be measured without the endoscopists' knowledge of being monitored.
During a subsequent 3-month period the same endoscopists will perform further 500 colonoscopies with standard and FUSE scopes using dedicated inspection techniques and a minimum 6-minute withdrawal time. In this second phase withdrawal times will be again measured, but endoscopists will be aware of being monitored.
The following parameters will be recorded:
* Demographic and general characteristics
* Indications to colonoscopy
* Colonoscopy findings
* Quality of preparation: Boston scale
* Time to reach the coecum
* Withdrawal time The adenoma detection rate and the mean adenomas per patients will be calculated.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard scope-short time
Standard colonoscopy with unmonitored withdrawal time
Colonoscopy
Colonoscopy performed in adult consecutive patients for different indications
FUSE scope-short time
Wide-angle colonoscopy with unmonitored withdrawal time
Colonoscopy
Colonoscopy performed in adult consecutive patients for different indications
Standard scope-long time
Standard colonoscopy with monitored withdrawal time
Colonoscopy
Colonoscopy performed in adult consecutive patients for different indications
FUSE scope-long time
Wide-angle colonoscopy with monitored withdrawal time
Colonoscopy
Colonoscopy performed in adult consecutive patients for different indications
Interventions
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Colonoscopy
Colonoscopy performed in adult consecutive patients for different indications
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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ASST Rhodense
OTHER
Responsible Party
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gianpiero manes
Head of th Gastroenterology Unit
Principal Investigators
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gianpiero manes, MD
Role: PRINCIPAL_INVESTIGATOR
ASST Rhodense
Locations
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ASST Rhodense
Garbagnate Milanese, Lombardy, Italy
Countries
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Other Identifiers
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W-time
Identifier Type: -
Identifier Source: org_study_id
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