LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing: A Prospective, Colonoscopist-blinded, Randomized, Controlled Trial

Conditions
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Bowel Cleansing

Intervention / Treatment
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* Behavioral: LINE re-education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: LINE is a popular application (App) which can share free words, photos, videos and voice messages (http://line.me/en/). LINE is available on all smart phone devices and personal computer. LINE re-education before colonoscopy to confirm optimal bowel cleansing.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 300 Randomized to re-education group<br>LINE re-education of colon preparation | Behavioral: LINE re-education<br> <br> |
| No Intervention: 300 Randomized to control group<br>education of colon preparation 1 time in hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate bowel preparation | 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 | colon polyp detection rate during colonoscopy | Day 1 | 
| cecal intubation rate | cecal intubation rate | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LINE, Colonoscopy, Bowel cleansing