LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

NCT04054388 | Unknown DMC

• 1 other identifier: 201505020
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Cleansing

Keywords

LINE; Colonoscopy; Bowel cleansing

Outcome Measures

Primary Outcomes (1)

• Adequate bowel preparation

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

  Day 1

Secondary Outcomes (2)

• colon polyp detection rate

  Day 1

• cecal intubation rate

  Day 1

Study Arms (2)

300 Randomized to re-education group

EXPERIMENTAL

LINE re-education of colon preparation

Behavioral: LINE re-education

300 Randomized to control group

NO INTERVENTION

education of colon preparation 1 time in hospital

Interventions

LINE re-education BEHAVIORAL

300 Randomized to re-education group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients aged 18-80 years undergoing colonoscopy who will provide written informed consent will be eligible for participation in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Wei Yu Kao, M.D.

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Yu Kao, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: August 13, 2019
• Study Start: June 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: August 13, 2019

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)