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

Medical College of Wisconsin

Status: Withdrawn

Conditions: Patients Undergoing Screening or Surveillance Colonoscopy

Treatments: Drug: PEG+Asc; Drug: sulfate; Drug: PEG+E; Drug: P+MC

Study type: Interventional

Funder types: Other

Identifiers

NCT02124447

PRO00022505

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups

PEG+E

Active Comparator group

Description:

Split dose 4 liter polyethylene glycol with electrolytes

Treatment:

Drug: PEG+E

PEG+Asc

Active Comparator group

Description:

Split dose 2 liter polyethylene glycol with ascorbic acid

Treatment:

Drug: PEG+Asc

P+MC

Active Comparator group

Description:

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

Treatment:

Drug: P+MC

sulfate

Active Comparator group

Description:

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

Treatment:

Drug: sulfate