LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

Not Applicable

• Conditions: Bowel Cleansing
• Interventions: Behavioral: LINE re-education

• Registration Number: NCT04054388
• Lead Sponsor: Taipei Medical University Hospital

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-12-22
• Status Verified: 2017-07
• Study First Submitted QC: 2019-08-11
• Last Update Submitted: 2019-08-11
• Study First Posted: 2019-08-13
• Last Update Posted: 2019-08-13
• Primary Completion: 2020-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
300 Randomized to re-education group	LINE re-education	LINE re-education of colon preparation

Primary Outcome Measures

Name	Time	Method
Adequate bowel preparation	Day 1	total Ottawa score \<6 or Boston bowel preparation scale ≥ 6

Secondary Outcome Measures

Name	Time	Method
cecal intubation rate	Day 1	cecal intubation rate
colon polyp detection rate	Day 1	colon polyp detection rate during colonoscopy

Trial Locations

Locations (1)

Taipei Medical University hospital; 🇨🇳 Taipei, Taiwan