LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

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.

Full Title of Study: “LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing: A Prospective, Colonoscopist-blinded, Randomized, Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2020

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.

Interventions

  • Behavioral: LINE re-education

Arms, Groups and Cohorts

  • Experimental: 300 Randomized to re-education group
    • LINE re-education of colon preparation
  • No Intervention: 300 Randomized to control group
    • education of colon preparation 1 time in hospital

Clinical Trial Outcome Measures

Primary Measures

  • Adequate bowel preparation
    • Time Frame: Day 1
    • total Ottawa score <6 or Boston bowel preparation scale ≥ 6

Secondary Measures

  • colon polyp detection rate
    • Time Frame: Day 1
    • colon polyp detection rate during colonoscopy
  • cecal intubation rate
    • Time Frame: Day 1
    • cecal intubation rate

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taipei Medical University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wei Yu Kao, M.D., Principal Investigator, Taipei Medical University Hospital
  • Overall Contact(s)
    • Wei Yu Kao, M.D., 886-2-27372181, 121021@tmuh.org.tw

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