LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

Bowel Cleansing Clinical Trial

Official title:

LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing: A Prospective, Colonoscopist-blinded, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04054388
• Other study ID #: 201505020
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 2021

Study information

• Verified date: July 2017
• Source: Taipei Medical University Hospital
• Contact: Wei Yu Kao, M.D.
• Phone: 886-2-27372181
• Email: 121021[@]tmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Cleansing

Intervention

Behavioral:
• LINE re-education

Locations

Country	Name	City	State
Taiwan	Taipei Medical University hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate bowel preparation	total Ottawa score <6 or Boston bowel preparation scale = 6	Day 1
Secondary	colon polyp detection rate	colon polyp detection rate during colonoscopy	Day 1
Secondary	cecal intubation rate	cecal intubation rate	Day 1