- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06117553
Thorough Flushing Strategy During Colonoscopy Examination
February 10, 2024 updated by: Zhao Hang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Clinical Study on the Application of Thorough Flushing Strategy During Colonoscopy Examination
The investigators plan to adopt a thorough flushing strategy when withdrawing the endoscope, and have zero tolerance for the liquid and foam in the intestinal lumen.
Observe and compare the impact of this strategy with traditional limited degree suction methods on the results of colonoscopy.
The research group and the control group respectively adopted a thorough flushing strategy and a limited flushing strategy, and compared the total time of colonoscopy examination, the time of withdrawal, the detection rate of polyps, the detection rate of small polyps, and the amount of flushing fluid between the two groups.
Analyze the value of thorough flushing strategy for the efficiency and quality of colonoscopy examination.
Study Overview
Detailed Description
Most physicians do not adopt a strategy of complete suction of fluid from the intestinal lumen during colonoscopy.
There are both concerns about the time required for colonoscopy and the possibility of inability to thorough cleannig up.
Some endoscopists believe that the visual field for partial cleaning of fecal water is acceptable and does not affect observation.
This study aims to make an observation and comparison based on the existing problems mentioned above.
With the help of direct water injection system, the investigators plan to adopt a thorough flushing strategy when withdrawing the endoscope, and have zero tolerance for the liquid and foam in the intestinal lumen.
Observe and compare the impact of this strategy with traditional limited degree suction methods on the results of colonoscopy.
The research group and the control group respectively adopted a thorough flushing strategy and a limited flushing strategy, and compared the total time of colonoscopy examination, the time of withdrawal, the detection rate of polyps, the detection rate of small polyps, and the amount of flushing fluid between the two groups.
Analyze the value of thorough flushing strategy for the efficiency and quality of colonoscopy examination.
Study Type
Observational
Enrollment (Actual)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hang Zhao, Professor
- Phone Number: 8618621186288
- Email: zhaohang@shutcm.edu.cn
Study Locations
-
-
-
Shanghai, China
- Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
160 patients were selected for colonoscopy examination and randomly assigned to the study group and control group.
The two groups used a thorough flushing strategy and a limited flushing strategy to complete colonoscopy examination.
The research group adopted a thorough flushing strategy, while the control group adopted a limited flushing strategy.
The thorough flushing strategy refers to the thorough flushing of all liquid and foam accumulation areas during the inspection.
Make all the liquid accumulation parts in the intestinal cavity free of aspiratable liquid retention.
The limited flushing strategy refers to not pursuing full liquid suction, but flushing until it is clear enough for observation.
The limited flushing strategy is currently the conventional flushing method for colonoscopy.
Description
Inclusion Criteria:
- People without contraindications for colonoscopy
Exclusion Criteria:
- Patients diagnosed with colon polyps
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
limited
patients adopted limited flushing strategy
|
|
thorough
Thorough flushing strategy
|
The thorough flushing strategy refers to the thorough flushing of all liquid and foam accumulation areas during the inspection.
Make all liquid accumulation parts in the intestinal cavity free of aspiratable liquid retention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time of examination
Time Frame: 1week
|
the time from insertion to exit the anus
|
1week
|
time of insertion
Time Frame: 1week
|
the time from insertion to arriving at cecum
|
1week
|
time of withdrawl
Time Frame: 1week
|
the time from cecum to anus
|
1week
|
number of polyps
Time Frame: 1week
|
the number of polyps found
|
1week
|
location of polyps
Time Frame: 1week
|
the location of polyps found
|
1week
|
shape of polyps
Time Frame: 1week
|
the shape of polyps found, classified into lateral, senssile and pediculated three types
|
1week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Boston score
Time Frame: 1week
|
the Boston score of bowel preparation (from 0-9)
|
1week
|
volume of water
Time Frame: 1week
|
volume of water used for flushing
|
1week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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)
August 1, 2023
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
January 31, 2024
Study Registration Dates
First Submitted
October 26, 2023
First Submitted That Met QC Criteria
November 3, 2023
First Posted (Actual)
November 7, 2023
Study Record Updates
Last Update Posted (Actual)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 10, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY-103-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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