Assessment of Combined Bowel Preparation for Capsule Endoscopy Study (CEPREP)
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|ClinicalTrials.gov Identifier: NCT01243736|
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Hemorrhage||Drug: Combination Prep||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Assessment of Combined Bowel Preparation for Capsule Endoscopy Study|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
No Intervention: Standard prep
One group will receive the standard bowel preparation, which consists of eating no solid foods after 7 p.m. the evening prior to the capsule endoscopy test and being able to consume clear liquids up to 4 hours prior to the capsule endoscopy test
Active Comparator: Combination Prep
The other group will receive the combination bowel preparation, which consists of taking the standard bowel preparation plus:
Drug: Combination Prep
combination bowel preparation, which consists of:
- Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy [ Time Frame: 1 year ]The primary endpoints of small bowel visualization quality, diagnostic yield, and completion rate will be compared between groups using Pearson's chi-square test.
- Safety outcomes and Patient satisfaction [ Time Frame: 1 year ]secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test.
- gastric transit time [ Time Frame: 1 year ]A group comparison for the secondary outcome of gastric transit time will be done using a two-sample t-test or Wilcoxon rank-sum test, as appropriate.
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): NCT01243736
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Stephanie L. Hansel, M.D.||Mayo Clinic|
|Principal Investigator:||Elizabeth Rajan, M.D.||Mayo Clinic|