LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing: A Prospective, Colonoscopist-blinded, Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Adequate bowel preparation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Masking Description
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
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
300 Randomized to re-education group
LINE re-education of colon preparation
Intervention: LINE re-education (Behavioral)
300 Randomized to control group
education of colon preparation 1 time in hospital
Outcomes
Primary Outcomes
Adequate bowel preparation
Time Frame: Day 1
total Ottawa score \<6 or Boston bowel preparation scale ≥ 6
Secondary Outcomes
- cecal intubation rate(Day 1)
- colon polyp detection rate(Day 1)