Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

Phase 1

Completed

• Conditions: Gastrointestinal Hemorrhage
• Interventions: Drug: Combination Prep

• Registration Number: NCT01243736
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age > 18 years old
2. Gastrointestinal bleeding as indication for capsule endoscopy.
3. Ability to give informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Prep	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Safety outcomes and Patient satisfaction	1 year	secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States