Patients Undergoing Screening or Surveillance Colonoscopy Clinical Trial
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.
| Verified date | July 2015 |
| Source | Medical College of Wisconsin |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2015 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Screening
| Country | Name | City | State |
|---|---|---|---|
| United States | Froedtert Hospital & The Medical College of Wisconsin | Milwaukee | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| Medical College of Wisconsin |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Patient tolerability and satisfaction | Will be assessed using a previously studied satisfaction questionnaire (7 items) | 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 | No |