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

NCT02124447 — Not applicable, Withdrawn, Medical College of Wisconsin

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Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.

RegistryNCT02124447
StatusWithdrawn - Protocol issues. Modifications potentially will be undertaken and resubmitted to IRB
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, screening
SponsorMedical College of Wisconsin (Other)
ConditionsPatients Undergoing Screening or Surveillance Colonoscopy
InterventionsPEG+E, PEG+Asc, P+MC, sulfate (Drug)
Datesstart 2014-06-01, primary completion 2014-08-01 (estimated), completion 2015-06-01 (estimated), first posted 2014-04-28, last updated 2015-07-10
Locations1 site in United States

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-Summary

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

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

+Arms and interventions

ArmTypeInterventionsDescription
PEG+EActive comparatorDrug: PEG+ESplit dose 4 liter polyethylene glycol with electrolytes
PEG+AscActive comparatorDrug: PEG+AscSplit dose 2 liter polyethylene glycol with ascorbic acid
P+MCActive comparatorDrug: P+MCSplit dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
sulfateActive comparatorDrug: sulfateSplit dose sodium sulfate, magnesium sulfate, and potassium sulfate solution
  • PEG+E (Drug), also known as Golytely: Split dose 4 liter polyethylene glycol with electrolytes
  • PEG+Asc (Drug), also known as MoviPrep: Split dose 2 liter polyethylene glycol with ascorbic acid
  • P+MC (Drug), also known as Suprep: Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
  • sulfate (Drug), also known as Prepopik: Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution

+Outcome measures

Primary outcomes

  • Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS) [Patient outcome will be assessed at the time of the colonoscopy by the performing physician and ducomentation of this outcome will occur within 24 hours of the procedure]

Secondary outcomes

  • Patient tolerability and satisfaction [Outcome of satisfaction will be assessed on a single survey that the patient will provide the day of their colonoscopy and will be recorded by study personnel up to 30 days thereafter]: Will be assessed using a previously studied satisfaction questionnaire (7 items)

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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

+Locations (1)

FacilityCityCountryStatus
Froedtert Hospital & The Medical College of WisconsinMilwaukee, WisconsinUnited States

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