- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04160104
Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy
November 8, 2019 updated by: Yanglin Pan, Air Force Military Medical University, China
Bowel preparation is closely llined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense.
For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies.
Thus, it is important to set up a model to predict the quality of bowel preparation individually.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1600
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: Hui Jia, MD
- Phone Number: +86-2984771536
- Email: jiahuifmmu@163.com
Study Locations
-
-
-
Xi'an, China, 710032
- Recruiting
- Endoscopic center, Xijing Hospital of Digestive Diseases
-
Contact:
- Hui Jia, MD
- Phone Number: +862984771536
- Email: jiahuifmmu@163.com
-
Principal Investigator:
- Yanglin Pan, MD
-
-
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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This is a prospective study involving two tertiary-centers in China.
Description
Inclusion Criteria:
- Patients aged 18-90 years old who undergoing colonoscopy
Exclusion Criteria:
- failed colonoscopy because of technical chanllenge or poor tolerance of patients
- history of colorectal surgery
- prior finding of severe colonic stricture or obstructing tumor
- dysphagia
- compromised swallowing reflex or mental status
- significant gastroparesis or gastric outlet obstruction or ileum
- known or suspected bowel obstruction or perforation
- pregnancy
- unable to give informed consent
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
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Training cohort
This cohort was used to establish the bowel preparation score (BPS).
|
Patients were asked to complete a questionnaire before colonoscopy.
Bowel preparation was subsequently assessed by single endoscopist in each center using Boston bowel preparation quality score (BBPS).
Both univariate and multivariate logistic regression models were used to identify high-risk factors associated with IBP and a predicting model with the bowel preparation score (BPS) was developed in the training cohort.
|
Validation cohort
This cohort was used to verify the bowel preparation score (BPS).
|
Patients were asked to complete a questionnaire before colonoscopy.
The predicting modle established by the training cohort will be used to assessing the preparation of validation cohort.
The result will compared with endoscopists assessment of preparation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Boston bowel preparation quality scale
Time Frame: 1 hour
|
A 10-point scale (0 is worst, 9 is best)
|
1 hour
|
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)
April 1, 2019
Primary Completion (Anticipated)
November 30, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
November 8, 2019
First Submitted That Met QC Criteria
November 8, 2019
First Posted (Actual)
November 12, 2019
Study Record Updates
Last Update Posted (Actual)
November 12, 2019
Last Update Submitted That Met QC Criteria
November 8, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KT20190827-2
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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