Assessment of Combined Bowel Preparation for Capsule Endoscopy Study (CEPREP)
The investigators are conducting a study to see if taking a bowel preparation before having a capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM the night before a capsule endoscopy in making it easier to see the small bowel in order to find the source of gastrointestinal bleeding.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Assessment of Combined Bowel Preparation for Capsule Endoscopy Study|
- Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test.
- gastric transit time [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2010|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
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:
This is a single-blind, prospective randomized controlled study to determine if a combination of purgative agent, prokinetic agent, simethicone, and position will improve small bowel visualization, diagnostic yield, and completion rate of capsule endoscopy.
Please refer to this study by its ClinicalTrials.gov identifier: 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|