LINE Re-education Before Colonoscopy to Confirm Optimal B... | NCT04054388

Studies
LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

NCT04054388

Sponsor

Taipei Medical University Hospital

Status

Unknown status

Last Update Posted

Aug 13, 2019Actual

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Bowel Cleansing

Interventions

LINE re-education

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Jun 2020Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Dec 22, 2016

First Submission Date that Met QC Criteria

Aug 11, 2019

First Posted Date

Aug 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2019

Last Update Posted Date

Aug 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LINE re-education	Behavioral		300 Randomized to re-education group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei Yu Kao, M.D.	Contact	886-2-27372181	3577	121021@tmuh.org.tw

Overall Officials

Name	Affiliation	Role
Wei Yu Kao, M.D.	Taipei Medical University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University hospital	Recruiting	Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention 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 Info

Masking

Single

Masking Description

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.

Who Masked

Investigator