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Impact of Reinforced Education by Video on the Quality of Bowel Preparation

Primary Purpose

Bowel Preparation Scale, Adenoma Detection Rate

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Video
Standard preparation instructions
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bowel Preparation Scale focused on measuring Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • outpatients aged 18-80 years
  • referred for routine diagnostic colonoscopy
  • with access to the educational video themselves or through close family members living in the same household were eligible.

Exclusion Criteria:

  1. pregnancy or breastfeeding
  2. allergy to purgatives
  3. suspected intestinal obstruction, stricture, or perforation
  4. hemodynamic instability
  5. impaired swallowing reflex or mental status
  6. severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure
  7. illiteracy
  8. history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery
  9. participation declined.

Sites / Locations

  • Changhai Hospital, Second Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Video

Standard preparation instructions

Arm Description

Patients randomized to the intervention arm will be contacted 48-72h before their procedure via telephone using a standardized script and will be provided a link to a website allowing posting of videos for public viewing

The control arm will receive written instruction on preparing for a colonoscopy per standard of care

Outcomes

Primary Outcome Measures

Boston Bowel Preparation Scale
The primary end point of the study was adequate bowel prepara- tion quality de ned as a BBPS total score of ≥6 with all segment scores ≥2

Secondary Outcome Measures

Polyp detection rate
Secondary end points included polyp detection rate which would be higher in the colonoscopy with satisfactory bowel preparation.
Adenoma detection rate
Secondary end points included adenoma detection rate which would be higher in the colonoscopy with satisfactory bowel preparation.

Full Information

First Posted
April 26, 2017
Last Updated
June 9, 2017
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03185299
Brief Title
Impact of Reinforced Education by Video on the Quality of Bowel Preparation
Official Title
Impact of Reinforced Education by Video on the Quality of Bowel Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 4, 2017 (Anticipated)
Primary Completion Date
June 4, 2018 (Anticipated)
Study Completion Date
August 4, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of reinforced education by Video on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. Reinforced education groups received additional education via reminders by video 2 days before colonoscopy. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Preparation Scale, Adenoma Detection Rate
Keywords
Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Video
Arm Type
Experimental
Arm Description
Patients randomized to the intervention arm will be contacted 48-72h before their procedure via telephone using a standardized script and will be provided a link to a website allowing posting of videos for public viewing
Arm Title
Standard preparation instructions
Arm Type
Experimental
Arm Description
The control arm will receive written instruction on preparing for a colonoscopy per standard of care
Intervention Type
Other
Intervention Name(s)
Video
Intervention Description
Patients randomized to the intervention arm will be contacted 48-72h before their procedure via telephone using a standardized script and will be provided a link to a website allowing posting of videos for public viewing
Intervention Type
Other
Intervention Name(s)
Standard preparation instructions
Intervention Description
The control arm will receive written instruction on preparing for a colonoscopy per standard of care
Primary Outcome Measure Information:
Title
Boston Bowel Preparation Scale
Description
The primary end point of the study was adequate bowel prepara- tion quality de ned as a BBPS total score of ≥6 with all segment scores ≥2
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Polyp detection rate
Description
Secondary end points included polyp detection rate which would be higher in the colonoscopy with satisfactory bowel preparation.
Time Frame
2 days
Title
Adenoma detection rate
Description
Secondary end points included adenoma detection rate which would be higher in the colonoscopy with satisfactory bowel preparation.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: outpatients aged 18-80 years referred for routine diagnostic colonoscopy with access to the educational video themselves or through close family members living in the same household were eligible. Exclusion Criteria: pregnancy or breastfeeding allergy to purgatives suspected intestinal obstruction, stricture, or perforation hemodynamic instability impaired swallowing reflex or mental status severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure illiteracy history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery participation declined.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaoshen Li, Prof
Phone
+86-21-31161335
Email
zhaosli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Bai, M.D.
Phone
+86-21-31161335
Email
baiyu1998@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Yu, Prof
Organizational Affiliation
Changhai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27753434
Citation
Rice SC, Higginbotham T, Dean MJ, Slaughter JC, Yachimski PS, Obstein KL. Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial. Am J Gastroenterol. 2016 Nov;111(11):1564-1571. doi: 10.1038/ajg.2016.450. Epub 2016 Oct 18.
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Impact of Reinforced Education by Video on the Quality of Bowel Preparation

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