- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04054388
LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing
August 11, 2019 updated by: Taipei Medical University Hospital
LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing: A Prospective, Colonoscopist-blinded, Randomized, Controlled Trial
This is a prospective, colonoscopist-blinded, randomized, controlled study with consecutive outpatients undergoing colonoscopy in Taipei Medical University Hospital.The study would comply with the standards of the Declaration of Helsinki and current ethical guidelines.
It have been approval by Taipei Medical University Institutional Review Board.
Study Overview
Detailed Description
Written informed consent will be obtained from all the patients.
Patients will be randomized to either the LINE re-education or control group for colon preparation at the time of appointment for colonoscopy by using consecutively numbered envelopes that will contain the treatment assignments, which will be generated by a computer-allocated random digit number, in a 1:1 ratio.
At least two LINE accounts for all patients or their relatives living together will be recorded in case of failure to contact.
All patients will be instructed not to tell colonoscopists, nurses and investigators before, during and after the procedure about their preparation method and when they receive instructions.
Study Type
Interventional
Enrollment (Anticipated)
600
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 Contact
- Name: Wei Yu Kao, M.D.
- Phone Number: 3577 886-2-27372181
- Email: 121021@tmuh.org.tw
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- Taipei Medical University Hospital
-
Contact:
- Wei Yu Kao, M.D.
- Phone Number: 3577 886-2-27372181
- Email: 121021@tmuh.org.tw
-
-
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
Description
Inclusion Criteria:
- Outpatients aged 18-80 years undergoing colonoscopy who will provide written informed consent will be eligible for participation in the study.
Exclusion Criteria:
- history of colorectal surgery;
- severe colonic stricture or obstructing tumor;
- uncooperative mental status;
- significant ileus;
- known or suspected bowel obstruction or perforation;
- severe chronic renal failure (creatinine clearance <30 ml/min);
- severe congestive heart failure (New York Heart Association class III or IV);
- uncontrolled hypertension (systolic blood pressure >180 mm Hg, diastolic blood pressure>100 mm Hg);
- liver cirrhosis;
- toxic colitis or megacolon;
- active gastrointestinal bleeding;
- dehydration or disturbance of electrolytes;
- pregnancy or lactation; and
- hemodynamically unstable.
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: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 300 Randomized to re-education group
LINE re-education of colon preparation
|
|
NO_INTERVENTION: 300 Randomized to control group
education of colon preparation 1 time in hospital
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequate bowel preparation
Time Frame: Day 1
|
total Ottawa score <6 or Boston bowel preparation scale ≥ 6
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
colon polyp detection rate
Time Frame: Day 1
|
colon polyp detection rate during colonoscopy
|
Day 1
|
cecal intubation rate
Time Frame: Day 1
|
cecal intubation rate
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wei Yu Kao, M.D., Taipei Medical University Hospital
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)
June 1, 2015
Primary Completion (ANTICIPATED)
June 1, 2020
Study Completion (ANTICIPATED)
June 1, 2021
Study Registration Dates
First Submitted
December 22, 2016
First Submitted That Met QC Criteria
August 11, 2019
First Posted (ACTUAL)
August 13, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 13, 2019
Last Update Submitted That Met QC Criteria
August 11, 2019
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 201505020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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