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NCT01099553 Clinical Trial

Improving Bowel Preparation With an Educational Video

Bowel Preparation Clinical Trial

Official title:
Improving Bowel Preparation With an Education Video

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01099553
Other study ID # H-29152
Secondary ID
Status Completed
Phase Phase 3
First received April 2, 2010
Last updated August 29, 2012
Start date March 2010
Est. completion date November 2011

Study information
Verified date August 2012
Source Boston Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators goal is to improve bowel preparations with an educational video on the Center for Digestive Disorders (CDD) website that explains the steps required for bowel preparation for those patients undergoing screening colonoscopies. The video will focus on explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the pre-colonoscopy diet, and the instructions for completing the laxative. In a randomized fashion, patients in the control group will receive the standard written bowel preparation instructions, while patients in the intervention group will receive standard written instructions plus a link to watch the instructional video. The investigators hypothesize that an educational tool that provides visual examples of a good and poor preparation, examples of the pre-colonoscopy diet, and an explanation of how to administer the laxative will lead to improved patient compliance and a better bowel preparation. In addition, the investigators hypothesize that a better quality bowel preparation will improve detection of colonic polyps and fewer recommendations for repeat colonoscopy based solely on inadequate bowel preparation.

Recruitment information / eligibility
Status Completed
Enrollment 2000
Est. completion date November 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- all outpatients

- age >18

- referred and scheduled for an elective screening colonoscopy

Exclusion Criteria:

- inpatients

- prisoners

- patients allergic to PEG-ELS based laxatives

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Educational video
Instructions to view an educational video about preparing for a colonoscopy
• Written instructions
Written instructions on preparing for a colonoscopy

Locations
Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of bowel preparation The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale Day of colonoscopy only No
Secondary Histology of polyp number of adenomatous polyps one week after colonoscopy No
Secondary Colonoscope insertion and withdrawal times time from insertion to cecum and time from cecum to anus Day of colonoscopy only No
Secondary Patient compliance Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire Day of colonoscopy only No
Secondary Preparation associated side effects Presence and severity of preparation associated side effects including: blaoting, abdominal pain, and nausea/vomiting Day of colonoscopy only No
Secondary Patient satisfaction patient's perception of the helpfulness of the video as self-reported on a pre-procedure questionnaire. Day of colonoscopy only No
Secondary Number of repeat colonoscopies due to inadequate bowel preparation Blinded endoscopist's assesment about the need for a repeat colonoscopy due to inadequate bowel preparation Day of colonoscopy only No
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