Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.
| Registry | NCT02124447 |
|---|---|
| Status | Withdrawn - Protocol issues. Modifications potentially will be undertaken and resubmitted to IRB |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, screening |
| Sponsor | Medical College of Wisconsin (Other) |
| Conditions | Patients Undergoing Screening or Surveillance Colonoscopy |
| Interventions | PEG+E, PEG+Asc, P+MC, sulfate (Drug) |
| Dates | start 2014-06-01, primary completion 2014-08-01 (estimated), completion 2015-06-01 (estimated), first posted 2014-04-28, last updated 2015-07-10 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Patients Undergoing Screening or Surveillance Colonoscopy All trials of PEG+E All trials of PEG+Asc
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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PEG+E | Active comparator | Drug: PEG+E | Split dose 4 liter polyethylene glycol with electrolytes |
| PEG+Asc | Active comparator | Drug: PEG+Asc | Split dose 2 liter polyethylene glycol with ascorbic acid |
| P+MC | Active comparator | Drug: P+MC | Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid |
| sulfate | Active comparator | Drug: sulfate | Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution |
Sex: All, ages: 18 Years to 90 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Froedtert Hospital & The Medical College of Wisconsin | Milwaukee, Wisconsin | United States |