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

University of Oklahoma (OU)

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Drug: Golytely (polyethylene glycol electrolyte lavage solution) and placebo; Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl; Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01533688

2869

Details and patient eligibility

About

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.

Enrollment: 212 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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212 participants in 3 patient groups, including a placebo group

Golytely + placebo

Active Comparator group

Description:

4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill

Treatment:

Drug: Golytely (polyethylene glycol electrolyte lavage solution) and placebo

Golytely Split + placebo

Placebo Comparator group

Description:

split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill

Treatment:

Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo

Golytely Split + Bisacodyl

Experimental group

Description:

split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg

Treatment:

Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl