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

Efficacy and Tolerability of Various Bowel Preparations in Diabetic Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Golytely + placebo; 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill	Drug: Golytely (polyethylene glycol electrolyte lavage solution) and placebo; 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
Placebo Comparator: Golytely Split + placebo; split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill	Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo; split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
Experimental: Golytely Split + Bisacodyl; split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg	Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl; split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Mohammad Madhoun, MD, University of Oklahoma Health Science Center

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 19, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (Estimate): February 15, 2012

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Pharmaceutical Solutions; Bisacodyl
• Other Study ID Numbers: 2869