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

NCT01533688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2018-09-07

Study results available
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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.

Conditions

Interventions

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

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

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

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Mohammad Madhoun, MD · University of Oklahoma Health Science Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01533688 on ClinicalTrials.gov