Gastrointestinal Hemorrhage
Conditions
Keywords
anemic, bleeding, blood in stool, abdomen pain, Gastrointestinal bleeding, capsule endoscopy (CE)
Brief summary
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.
Detailed description
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.
Interventions
DRUGCombination Prep
combination bowel preparation, which consists of: 1. drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test; 2. drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test; 3. drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test; 4. lying on your right side for 30 minutes following the swallowing of the capsule endoscope.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years old 2. Gastrointestinal bleeding as indication for capsule endoscopy. 3. Ability to give informed consent
Exclusion criteria
1. Subject has an allergy to polyethylene glycol or other adverse reaction to a previous bowel preparation with PEG3350 (MoviPrep®), metoclopramide, or simethicone; 2. Subjects has gastrointestinal motility disorder; 3. Subjects had stomach or small bowel resection; 4. Pregnancy; 5. Subjects has pheochromocytoma; 6. Subjects has uncontrolled hypertension; 7. Subjects has seizure disorders; 8. Subjects has concurrent MAO inhibitor use; 9. Subject has G6PD deficiency; 10. Subjects has swallowing disorder (including impaired gag reflex); 11. Subjects has hyponatremia with serum sodium less than 130 mm0l/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety outcomes and Patient satisfaction | 1 year | secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test. |
| gastric transit time | 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. |
Countries
United States
Outcome results
None listed