Study Stopped
Protocol issues. Modifications potentially will be undertaken and resubmitted to IRB
Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy
Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2014
CompletedFirst Posted
Study publicly available on registry
April 28, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 10, 2015
July 1, 2015
2 months
April 23, 2014
July 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (4)
PEG+E
ACTIVE COMPARATORSplit dose 4 liter polyethylene glycol with electrolytes
PEG+Asc
ACTIVE COMPARATORSplit dose 2 liter polyethylene glycol with ascorbic acid
P+MC
ACTIVE COMPARATORSplit dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
sulfate
ACTIVE COMPARATORSplit dose sodium sulfate, magnesium sulfate, and potassium sulfate solution
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- History of inadequate colon preparation on any prior colonoscopies
- Patient is pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Froedtert Hospital & The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division of Gastroenterology
Study Record Dates
First Submitted
April 23, 2014
First Posted
April 28, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2014
Study Completion
June 1, 2015
Last Updated
July 10, 2015
Record last verified: 2015-07