Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.

Overview

The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are blinded to the randomization process.

Full Title of Study: “A Randomized Endoscopist-blinded Clinical Trial Comparing the Bowel Cleansing Effect and Patient Tolerability of Same Day Polyethylene Glycol Bowel Preparation Regimen v Regimen Given on the Day Before Colonoscopy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: July 2009

Detailed Description

Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as "Golytely" will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel preparation. For the afternoon colonoscopies, the conventional PEG regimen given on the evening prior to the day of the colonoscopy will be compared with the novel PEG regimen given on the morning of the day of the colonoscopy. The comparison will be drawn for two measures – bowel cleansing effect measured from the questionnaire given to the gastroenterologists performing the colonoscopy and the patient tolerability evaluated from the information gathered from the patient's questionnaire.

Interventions

  • Drug: Polyethylene Glycol afternoon
    • Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM
  • Drug: Polyethylene Glycol morning
    • Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM

Arms, Groups and Cohorts

  • Active Comparator: Polythylene Glycol (PEG) in the evening
    • Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy. ‘Polyethylene Glycol afternoon’
  • Experimental: Polythylene Glycol (PEG) in the Morning
    • Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy. ‘Polyethylene Glycol morning’

Clinical Trial Outcome Measures

Primary Measures

  • Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.
    • Time Frame: Within 1 hr after the colonoscopy procedure

Secondary Measures

  • Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.
    • Time Frame: An hour before the colonoscopy procedure
    • Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.

Participating in This Clinical Trial

Inclusion Criteria

  • All patients attending the GI Clinic at CCF who are prescribed colonoscopy and are willing to get the procedure done in the afternoon. Exclusion Criteria:

  • Colonoscopy is contraindicated – Prior Colectomy or colon surgery.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cleveland Clinic Florida
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shibu Varughese, M.D., Principal Investigator, Cleveland Clinic Florida

Citations Reporting on Results

Varughese S, Kumar AR, George A, Castro FJ. Morning-only one-gallon polyethylene glycol improves bowel cleansing for afternoon colonoscopies: a randomized endoscopist-blinded prospective study. Am J Gastroenterol. 2010 Nov;105(11):2368-74. doi: 10.1038/ajg.2010.271. Epub 2010 Jul 6.

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