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Status unknownNCT04054388Updated Aug 13, 2019

LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

An interventional study of LINE re-education in Bowel Cleansing, sponsored by Taipei Medical University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-13.

Sponsored by Taipei Medical University Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jun 2015, registered Dec 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bowel Cleansing

Keywords

  • LINE
  • Colonoscopy
  • Bowel cleansing
03

In context

Lead sponsor

Taipei Medical University Hospital is the lead sponsor of 62 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    300 Randomized to re-education group

    LINE re-education of colon preparation

    Behavioral: LINE re-education

  • No intervention
    300 Randomized to control group

    education of colon preparation 1 time in hospital

Interventions

  • BehavioralLINE re-education
06

What researchers measure

Primary outcomes

  1. Adequate bowel preparation

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

    Time frame: Day 1

Secondary outcomes

  1. colon polyp detection rate

    colon polyp detection rate during colonoscopy

    Time frame: Day 1

  2. cecal intubation rate

    cecal intubation rate

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
  • Taipei Medical University hospital
    Taipei, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04054388
Lead sponsor
Taipei Medical University Hospital
Responsible party
Sponsor
First posted
Aug 13, 2019
Start date
Jun 2015
Primary completion
Jun 2020 (estimated)
Completion
Jun 2021 (estimated)
Last update
Aug 13, 2019

Study contacts

Wei Yu Kao, M.D.
Contact
121021@tmuh.org.tw
886-2-27372181 ext. 3577
Wei Yu Kao, M.D.
principal investigator · Taipei Medical University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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