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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533688
• Other study ID #: 2869
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: October 2016

Study information

• Verified date: August 2018
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Oklahoma VA Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	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