Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-06-30

Brief Summary

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This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.

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Detailed Description

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We will randomize 300 consecutive patients undergoing colonoscopy for screening or surveillance purposes to receive one of four bowel purgatives. These purgatives include

1. Split dose 4 liter polyethylene glycol with electrolytes (PEG+E): Brand name GoLytely
2. Split dose 2 liter polyethylene glycol with ascorbic acid (PEG+Asc): Brand name: MoviPrep
3. Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid (P+MC): Brand name Prepopik
4. Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution (sulfate): Brand name Suprep

Conditions

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Patients Undergoing Screening or Surveillance Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Caregivers

Study Groups

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PEG+E

Split dose 4 liter polyethylene glycol with electrolytes

Group Type ACTIVE_COMPARATOR

PEG+E

Intervention Type DRUG

Split dose 4 liter polyethylene glycol with electrolytes

PEG+Asc

Split dose 2 liter polyethylene glycol with ascorbic acid

Group Type ACTIVE_COMPARATOR

PEG+Asc

Intervention Type DRUG

Split dose 2 liter polyethylene glycol with ascorbic acid

P+MC

Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid

Group Type ACTIVE_COMPARATOR

P+MC

Intervention Type DRUG

Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid

sulfate

Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution

Group Type ACTIVE_COMPARATOR

sulfate

Intervention Type DRUG

Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution

Interventions

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PEG+E

Split dose 4 liter polyethylene glycol with electrolytes

Intervention Type DRUG

PEG+Asc

Split dose 2 liter polyethylene glycol with ascorbic acid

Intervention Type DRUG

P+MC

Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid

Intervention Type DRUG

sulfate

Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution

Intervention Type DRUG

Other Intervention Names

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Golytely MoviPrep Suprep Prepopik

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or greater
2. Ability to understand and complete questionnaires
3. Ability to speak and read English
4. Willingness to participate in study
5. Colonoscopy is being performed for routine screening (i.e. no prior personal history of polyps or cancer) or surveillance (i.e. follow up for a personal history of polyps) purposes

Exclusion Criteria

1. Previous bowel resection of any kind (small or large bowel)
2. End stage renal disease (ESRD)
3. Contraindication to bowel purgative
4. Necessity for inpatient admission to receive bowel preparation for any reason
5. Currently taking any narcotic/opiate pain or anticholinergic medication (since these may predispose to higher colon stool burden at baseline)
6. Currently taking stool softeners (e.g. Miralax, Amitiza, Linzess, lactulose) or stimulant laxatives (e.g. Dulcolax)
7. Subject did not follow appropriate dosing instructions for bowel purgative
8. Colonoscopy is being performed to evaluate a clinical symptom such as rectal bleeding, constipation, abdominal pain, or diarrhea
9. History of colon polyposis syndrome
10. Personal history of inflammatory bowel disease
11. History of inadequate colon preparation on any prior colonoscopies
12. Patient is pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No