Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.
Overview
- Phase
- Not Applicable
- Intervention
- PEG+E
- Conditions
- Patients Undergoing Screening or Surveillance Colonoscopy
- Sponsor
- Medical College of Wisconsin
- Locations
- 1
- Primary Endpoint
- Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS)
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief 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.
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
Investigators
Zachary Smith
Division of Gastroenterology
Medical College of Wisconsin
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or greater
- •Ability to understand and complete questionnaires
- •Ability to speak and read English
- •Willingness to participate in study
- •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
- •Previous bowel resection of any kind (small or large bowel)
- •End stage renal disease (ESRD)
- •Contraindication to bowel purgative
- •Necessity for inpatient admission to receive bowel preparation for any reason
- •Currently taking any narcotic/opiate pain or anticholinergic medication (since these may predispose to higher colon stool burden at baseline)
- •Currently taking stool softeners (e.g. Miralax, Amitiza, Linzess, lactulose) or stimulant laxatives (e.g. Dulcolax)
- •Subject did not follow appropriate dosing instructions for bowel purgative
- •Colonoscopy is being performed to evaluate a clinical symptom such as rectal bleeding, constipation, abdominal pain, or diarrhea
- •History of colon polyposis syndrome
- •Personal history of inflammatory bowel disease
Arms & Interventions
PEG+E
Split dose 4 liter polyethylene glycol with electrolytes
Intervention: PEG+E
PEG+Asc
Split dose 2 liter polyethylene glycol with ascorbic acid
Intervention: PEG+Asc
P+MC
Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
Intervention: P+MC
sulfate
Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution
Intervention: sulfate
Outcomes
Primary Outcomes
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 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)