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Assessment of Combined Bowel Preparation for Capsule Endoscopy Study (CEPREP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01243736
First Posted: November 18, 2010
Last Update Posted: January 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephanie L. Hansel, Mayo Clinic
  Purpose
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.

Condition Intervention Phase
Gastrointestinal Hemorrhage Drug: Combination Prep Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

Resource links provided by NLM:


Further study details as provided by Stephanie L. Hansel, Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: April 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  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.
Drug: Combination 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.
Other Names:
  • polyethylene glycol
  • simethicone
  • metoclopramide

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Stephanie L. Hansel, M.D. Mayo Clinic
Principal Investigator: Elizabeth Rajan, M.D. Mayo Clinic
  More Information

Responsible Party: Stephanie L. Hansel, Assistant Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01243736     History of Changes
Other Study ID Numbers: 10-000198
First Submitted: October 19, 2010
First Posted: November 18, 2010
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Stephanie L. Hansel, Mayo Clinic:
anemic
bleeding
blood in stool
abdomen pain
Gastrointestinal bleeding
capsule endoscopy (CE)

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Metoclopramide
Simethicone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antifoaming Agents
Emollients
Dermatologic Agents