Improving Bowel Preparation With an Educational Video
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ClinicalTrials.gov Identifier: NCT01099553 |
Recruitment Status
:
Completed
First Posted
: April 7, 2010
Last Update Posted
: August 31, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bowel Preparation | Other: Educational video Other: Written instructions | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Improving Bowel Preparation With an Education Video |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
Standard preparation instructions
The control arm will receive written instructions on preparing for a colonoscopy per standard of care at Boston Medical Center
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Other: Written instructions
Written instructions on preparing for a colonoscopy
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Experimental: Interventional
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus instructions asking them to watch an educational video on the Center for Digestive Disorders website
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Other: Educational video
Instructions to view an educational video about preparing for a colonoscopy
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- Quality of bowel preparation [ Time Frame: Day of colonoscopy only ]The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale
- Histology of polyp [ Time Frame: one week after colonoscopy ]number of adenomatous polyps
- Colonoscope insertion and withdrawal times [ Time Frame: Day of colonoscopy only ]time from insertion to cecum and time from cecum to anus
- Patient compliance [ Time Frame: Day of colonoscopy only ]Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
- Preparation associated side effects [ Time Frame: Day of colonoscopy only ]Presence and severity of preparation associated side effects including: blaoting, abdominal pain, and nausea/vomiting
- Patient satisfaction [ Time Frame: Day of colonoscopy only ]patient's perception of the helpfulness of the video as self-reported on a pre-procedure questionnaire.
- Number of repeat colonoscopies due to inadequate bowel preparation [ Time Frame: Day of colonoscopy only ]Blinded endoscopist's assesment about the need for a repeat colonoscopy due to inadequate bowel preparation

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099553
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Brian C Jacobson, MD, MPH | Boston Medical Center |
Responsible Party: | Brian Jacobson, Associate Professor of Medicine, Boston Medical Center |
ClinicalTrials.gov Identifier: | NCT01099553 History of Changes |
Other Study ID Numbers: |
H-29152 |
First Posted: | April 7, 2010 Key Record Dates |
Last Update Posted: | August 31, 2012 |
Last Verified: | August 2012 |
Keywords provided by Brian Jacobson, Boston Medical Center:
Educational video colonoscopy bowel preparation Bowel preparation for colonoscopy |