Impact of Reinforced Education by Video on the Quality of Bowel Preparation
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
July 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2018
CompletedJune 14, 2017
June 1, 2017
11 months
April 26, 2017
June 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 days
Secondary Outcomes (2)
Polyp detection rate
2 days
Adenoma detection rate
2 days
Study Arms (2)
Video
EXPERIMENTALPatients 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
Standard preparation instructions
EXPERIMENTALThe control arm will receive written instruction on preparing for a colonoscopy per standard of care
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital, Second Military Medical University
Shanghai, 200433, China
Related Publications (1)
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.
PMID: 27753434RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhaoshen Yu, Prof
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
April 26, 2017
First Posted
June 14, 2017
Study Start
July 4, 2017
Primary Completion
June 4, 2018
Study Completion
August 4, 2018
Last Updated
June 14, 2017
Record last verified: 2017-06