LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2021-06-30

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.

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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.

Conditions

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Bowel Cleansing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

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 Groups

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300 Randomized to re-education group

LINE re-education of colon preparation

Group Type EXPERIMENTAL

LINE re-education

Intervention Type BEHAVIORAL

300 Randomized to control group

education of colon preparation 1 time in hospital

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LINE re-education

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No