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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard prep | No Intervention | 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 | |
| Combination Prep | Active Comparator | The other group will receive the combination bowel preparation, which consists of taking the standard bowel preparation plus:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination Prep | Drug | combination bowel preparation, which consists of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy | The primary endpoints of small bowel visualization quality, diagnostic yield, and completion rate will be compared between groups using Pearson's chi-square test. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcomes and Patient satisfaction | secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test. | 1 year |
| gastric transit time | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie L. Hansel, M.D. | Mayo Clinic | Principal Investigator |
| Elizabeth Rajan, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32419949 | Derived | Hansel SL, Murray JA, Alexander JA, Bruining DH, Larson MV, Mangan TF, Dierkhising RA, Almazar AE, Rajan E. Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized-controlled study. Gastroenterol Rep (Oxf). 2019 Oct 19;8(1):31-35. doi: 10.1093/gastro/goz054. eCollection 2020 Feb. |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D006470 | Hemorrhage |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D012841 | Simethicone |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
|
| 1 year |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |