Patients Undergoing Screening or Surveillance Colonoscopy
Conditions
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
Interventions
DRUGPEG+E
Split dose 4 liter polyethylene glycol with electrolytes
DRUGPEG+Asc
Split dose 2 liter polyethylene glycol with ascorbic acid
DRUGP+MC
Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
DRUGsulfate
Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed