- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02105025
A Novel Clinically Usable Point Score To Prejudge The Complexity Of Colonoscopy
May 5, 2014 updated by: Yanglin Pan, Air Force Military Medical University, China
Colonoscopy is the current common method for management of colorectal diseases, and effectiveness of colonoscopy associate with complication rate.
A lot of patients were failed because of technical difficulty, those required more than 10 min to intubate the cecum are consider as difficult colonoscopy, in such condition, specialized equipment or maneuvers may be required for a successful colonoscopy.
Thus, it is important to set up a clinical model to predict the technical difficulty of the examination in preoperational stage.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
612
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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Shanxi
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Xi'an, Shanxi, China, 710032
- Endoscopic center, Xi jing Hospital of Digestive
-
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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 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This is a prospective study involving only one tertiary center in China.
The patients were enrolled from the Endoscopy Center of Xi jing Hospital of Digestive Diseases in China.
Description
Inclusion Criteria:
- patients aged 18-90 years old who undergoing colonoscopy without sedation
Exclusion Criteria:
- no bowel preparation or colon cleansing by enema only
- no need to reach cecum
- prior finding of severe colon stenosis or obstructing tumour
- history of colectomy
- unstable hemodynamics
- pregnant
- 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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cecal intubation time
Time Frame: up to 4 months
|
Total time of colonoscope intubation from anus to cecum.
|
up to 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
Helpful Links
- Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study
- Prospective evaluation of factors predicting difficulty and pain during sedation-free colonoscopy
- Colorectal cancer screening and surveillance: clinical guidelines and rationale-Update based on new evidence
- Factors associated with incomplete colonoscopy: a population-based study
- Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 liters) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy
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
December 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
March 28, 2014
First Submitted That Met QC Criteria
April 4, 2014
First Posted (Estimate)
April 7, 2014
Study Record Updates
Last Update Posted (Estimate)
May 6, 2014
Last Update Submitted That Met QC Criteria
May 5, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20131023-3
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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