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Completed

NCT Number: NCT01533688

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

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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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Golytely (polyethylene glycol electrolyte lavage solution) and placebo

Drug

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

Drug

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

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

Primary outcomes

  1. 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.

    Time frame: Day 1

    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.

Secondary outcomes

  1. Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.

    Time frame: 24 hours

    Number of Participants Who Developed Side Effects of Taking Bowel Preparations

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2012
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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