Clinical trial NCT04054388: LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing
Official title: LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing: A Prospective, Colonoscopist-blinded, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Cleansing
Keywords: LINE
Colonoscopy
Bowel cleansing
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adequate bowel preparation
timeFrame: Day 1
Secondary outcomes:
measure: colon polyp detection rate
timeFrame: Day 1
measure: cecal intubation rate
timeFrame: Day 1
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Wei Yu Kao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: