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LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

T

Taipei Medical University

Status

Unknown

Conditions

Bowel Cleansing

Treatments

Behavioral: LINE re-education

Study type

Interventional

Funder types

Other

Identifiers

NCT04054388
201505020

Details and patient eligibility

About

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 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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

600 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Wei Yu Kao, M.D.

Data sourced from clinicaltrials.gov

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