LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

August 11, 2019 updated by: Taipei Medical University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Taipei, Taiwan
        • Recruiting
        • Taipei Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
colon polyp detection rate
Time Frame: Day 1
colon polyp detection rate during colonoscopy
Day 1
cecal intubation rate
Time Frame: Day 1
cecal intubation rate
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wei Yu Kao, M.D., Taipei Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

August 11, 2019

First Posted (ACTUAL)

August 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 11, 2019

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 201505020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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