Clinical trial NCT02124447: Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy
Official title: 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: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Patients Undergoing Screening or Surveillance Colonoscopy
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS)
timeFrame: 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:
measure: Patient tolerability and satisfaction
timeFrame: 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
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital & The Medical College of Wisconsin
state: Wisconsin
Study officials:
References: