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

June 9, 2017 updated by: Zhaoshen Li, Changhai Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Changhai Hospital, Second Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Video
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
Other: Video
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
EXPERIMENTAL: Standard preparation instructions
The control arm will receive written instruction on preparing for a colonoscopy per standard of care
Other: Standard preparation instructions
The control arm will receive written instruction on preparing for a colonoscopy per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Bowel Preparation Scale
Time Frame: 2 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyp detection rate
Time Frame: 2 days
Secondary end points included polyp detection rate which would be higher in the colonoscopy with satisfactory bowel preparation.
2 days
Adenoma detection rate
Time Frame: 2 days
Secondary end points included adenoma detection rate which would be higher in the colonoscopy with satisfactory bowel preparation.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Study Chair: Zhaoshen Yu, Prof, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 4, 2017

Primary Completion (ANTICIPATED)

June 4, 2018

Study Completion (ANTICIPATED)

August 4, 2018

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (ACTUAL)

June 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIDEO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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