N/A
N=212
Study of Efficacy and Tolerability of Various Bowel Preps in Diabetic Patients
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01533688 ↗Enrolled (actual)
212
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy. — 42; 50; 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Golytely (polyethylene glycol electrolyte lavage solution) and placebo (Drug); split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo (Drug); split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy. |
42; 50; 47 | — |
| SECONDARY Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations. |
24; 28; 28 | — |
Summary
Poor bowel preparation and patient intolerance of the procedure are the most important factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in incomplete testing, increased potential to miss lesions, increased cost, and decreased patient satisfaction. The investigators hope to gain better insight into which bowel preparation works best in diabetic patients and hence would increase patient satisfaction, tolerability of the bowel preparation and decrease overall costs. The investigators will investigate which bowel preparation for colonoscopy will work optimally in diabetic patients using three different regimens.
Eligibility Criteria
Inclusion Criteria
- adult diabetic outpatients referred for elective colonoscopy
Exclusion Criteria
- patients 75 yrs of age,
- known or suspected pregnancy,
- known or suspected renal failure,
- unstable angina,
- acute coronary syndrome,
- decompensated congestive heart failure,
- decompensated liver failure,
- known or suspected bowel obstruction,
- major psychiatric illness,
- solid organ transplant patients,
- known allergies to PEG-ELS or bisacodyl,
- prior alimentary tract surgery or refusal to consent to the study.
Data sourced from ClinicalTrials.gov (NCT01533688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.