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|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||June 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.
|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|