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

Adenoma Detection Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03185299
• Other study ID #: VIDEO
• Status: Not yet recruiting
• Phase: N/A
• First received: April 26, 2017
• Last updated: June 9, 2017
• Start date: July 4, 2017
• Est. completion date: August 4, 2018

Study information

• Verified date: June 2017
• Source: Changhai Hospital
• Contact: Zhaoshen Li, Prof
• Phone: +86-21-31161335
• Email: zhaosli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Detection Rate
• Bowel Preparation Scale

Intervention

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

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & 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):1564-157 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Polyp detection rate	Secondary end points included polyp detection rate which would be higher in the colonoscopy with satisfactory bowel preparation.	2 days
Secondary	Adenoma detection rate	Secondary end points included adenoma detection rate which would be higher in the colonoscopy with satisfactory bowel preparation.	2 days