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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: August 2014

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

Interventions

  • Drug: PEG+E
    • Split dose 4 liter polyethylene glycol with electrolytes
  • Drug: PEG+Asc
    • Split dose 2 liter polyethylene glycol with ascorbic acid
  • Drug: P+MC
    • Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
  • Drug: sulfate
    • Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution

Arms, Groups and Cohorts

  • Active Comparator: PEG+E
    • Split dose 4 liter polyethylene glycol with electrolytes
  • Active Comparator: PEG+Asc
    • Split dose 2 liter polyethylene glycol with ascorbic acid
  • Active Comparator: P+MC
    • Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
  • Active Comparator: sulfate
    • Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS)
    • Time Frame: 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 Measures

  • Patient tolerability and satisfaction
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical College of Wisconsin
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zachary Smith, Division of Gastroenterology – Medical College of Wisconsin

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