Study of Efficacy and Tolerability of Various Bowel Preps in Diabetic Patients

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: 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

• Registration Number: NCT01533688
• Lead Sponsor: University of Oklahoma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-11-21
• Results First Submitted QC: 2018-07-13
• Status Verified: 2018-08
• Results First Posted: 2018-08-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• adult diabetic outpatients referred for elective colonoscopy

Exclusion Criteria

• patients < 18 years of age or > 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Golytely + placebo	Golytely (polyethylene glycol electrolyte lavage solution) and placebo	4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
Golytely Split + placebo	split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo	split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill
Golytely Split + Bisacodyl	split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl	split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg

Primary Outcome Measures

Name	Time	Method
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.	Day 1	The investigators will measure the number/% of participants who will have good to excellent bowel preparations defined by the Boston Bowel Prep Scale(BBPS) with a score of 6 or more, rated by blinded colonoscopist.

Secondary Outcome Measures

Name	Time	Method
Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.	24 hours	Number of Participants Who Developed Side Effects of Taking Bowel Preparations

Trial Locations

Locations (1)

Oklahoma VA Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States