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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Golytely + placebo

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

Group Type ACTIVE_COMPARATOR

Golytely (polyethylene glycol electrolyte lavage solution) and placebo

Intervention Type DRUG

4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy

Golytely Split + placebo

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes