- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03619122
Second Forward View Examination of Proximal Colon on Adenoma Detection Rate
July 11, 2019 updated by: Ningbo No. 1 Hospital
Impact of Second Forward View Examination of Proximal Colon on Adenoma Detection Rate: A Randomized Clinical Trial
This clinical trial is being conducted to assess whether second forward view examination of proximal colon could increase adenoma detection rate of right colon.
Study Overview
Study Type
Interventional
Enrollment (Actual)
392
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Ningbo, Zhejiang, China, 315010
- Ningbo NO.1 hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all patients undergoing colonoscopy for screening in our hospital
Exclusion Criteria:
- previous history of resection of colon;
- familial polyposis syndrome
- inflammatory bowel disease
- active antiplatelet or anticoagulant therapy prevent polypectomy;
- pregnancy or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Second Examination
Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care.
The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa.
Then, the colonoscope is inserted to the cecum and withdrawn to the hepatic flexure again for second examination.
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The colonoscopy is passed to the cecum and then withdrawn to hepatic flexure.
Then, the scopy is inserted to the cecum and withdrawn to hepatic flexure again for second foreard view examination.
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NO_INTERVENTION: Traditional Examinaiton
Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care.
The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa.
Then, the colonoscope is withdrawn to the anus directly.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
per-patient detection rate of adenoma of proximal colon
Time Frame: 1 day
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the number of patients with at least one adenoma identified divided by total number of patients completing colonoscopy
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2018
Primary Completion (ACTUAL)
May 31, 2019
Study Completion (ACTUAL)
June 30, 2019
Study Registration Dates
First Submitted
August 2, 2018
First Submitted That Met QC Criteria
August 2, 2018
First Posted (ACTUAL)
August 7, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 12, 2019
Last Update Submitted That Met QC Criteria
July 11, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-R014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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