LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

Taipei Medical University Hospital600 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

600

Conditions

Bowel Cleansing

Interventions

LINE re-educationBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taipei Medical University hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Adequate bowel preparation

total Ottawa score \<6 or Boston bowel preparation scale ≥ 6

Time frame: Day 1

Secondary Outcomes

colon polyp detection rate

colon polyp detection rate during colonoscopy

Time frame: Day 1

cecal intubation rate

Time frame: Day 1

Central Contacts

Wei Yu Kao, M.D.

CONTACT

886-2-27372181 121021@tmuh.org.tw

Data from ClinicalTrials.gov

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