Bowel Preparation Clinical Trial
Official title:
Improving Bowel Preparation With an Education Video
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center |
United States,
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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