Bowel CleansingNCT04054388
LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing
A study testing LINE re-education in people with Bowel Cleansing, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Cleansing
- What is being tested?
- LINE re-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2015to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients aged 18-80 years undergoing colonoscopy who will provide written informed consent will be eligible for participation in the study.
Who cannot join
- 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);
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- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University hospital
Taipei
Wei Yu Kao, M.D., 886-2-27372181 ext. 3577, 121021@tmuh.org.tw
About this study
Official title: 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.
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.
- Conditions
- Bowel Cleansing
- Being tested
- LINE re-education
- Keywords
- LINE, Colonoscopy, Bowel cleansing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINE re-educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 300 Randomized to re-education group | Experimental | LINE re-education of colon preparation Receives: Behavioral: LINE re-education |
| 300 Randomized to control group | No intervention | education of colon preparation 1 time in hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel preparation
total Ottawa score <6 or Boston bowel preparation scale ≥ 6
Measured: Day 1
Secondary outcomes (2)
colon polyp detection rate
colon polyp detection rate during colonoscopy
Measured: Day 1
cecal intubation rate
cecal intubation rate
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study startJun 2015
- Primary completionJun 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel CleansingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Yu Kao, M.D., Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054388
- Sponsor's protocol ID
- 201505020
- Status last verified
- Jul 2017
- First submitted
- 22 Dec 2016
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing: A Prospective, Colonoscopist-blinded, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04054388
- Acronym / sponsor ID
- 201505020
- Conditions
- Bowel Cleansing
- Keywords
- LINE, Colonoscopy, Bowel cleansing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 300 Randomized to re-education group | Experimental | Behavioral: LINE re-educationLINE re-education of colon preparation |
| 300 Randomized to control group | No intervention | –education of colon preparation 1 time in hospital |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients aged 18-80 years undergoing colonoscopy who will provide written informed consent will be eligible for participation in the study.
Key exclusion criteria (14 listed)
- history of colorectal surgery;
- severe colonic stricture or obstructing tumor;
- uncooperative mental status;
- significant ileus;
- known or suspected bowel obstruction or perforation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LINE re-education | Behavioural | 300 Randomized to re-education group |
Primary outcome
Adequate bowel preparation
Time frame: Day 1
total Ottawa score <6 or Boston bowel preparation scale ≥ 6
2 secondary outcomes
colon polyp detection rate
Time frame: Day 1
cecal intubation rate
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Yu Kao, M.D. principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LINE re-education in people with Bowel Cleansing, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Yu Kao, M.D. (886-2-27372181 ext. 3577, 121021@tmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate bowel preparation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.