The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies

Overview

The purpose of this study is to compare the efficacy of a low-volume bowel preparation versus a high-volume bowel preparation for bowel cleansing on hospitalized patients undergoing colonoscopies.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: March 2019

Interventions

  • Drug: Low volume prep (Prepopik)
    • Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
  • Drug: Moderate volume prep (Moviprep)
    • Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
  • Drug: High volume prep (Golytely)
    • Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.

Arms, Groups and Cohorts

  • Active Comparator: Low volume prep (Prepopik)
    • Low volume prep for colonoscopy (Prepopik)
  • Active Comparator: Moderate volume prep (Moviprep)
    • Moderate volume prep for colonoscopy (Moviprep)
  • Active Comparator: High volume prep (Golytely)
    • High volume prep for colonoscopy (Golytely)

Clinical Trial Outcome Measures

Primary Measures

  • Bowel Cleansing
    • Time Frame: 24 hours
    • Measured using the total Boston Bowel Prep Score (BBPS) obtained by adding scores from each segment for a range of minimum 0 = very poor and maximum 9 = excellent.

Secondary Measures

  • Cancellation or Delay of Procedure Due to Poor Bowel Preparation
    • Time Frame: 24 hours
    • To assess the rate of delayed and or cancellation of procedure due to inadequate bowel preparation

Participating in This Clinical Trial

Inclusion Criteria

1. Inpatient colonoscopy 2. Age 18 years and older 3. Able to give consent 4. Split dose colonoscopies for all patients Exclusion criteria:

1. Unable to give consent 2. Pregnant or lactating women 3. Renal impairment (GFR <30) 4. Ileus 5. Ascites 6. Toxic megacolon 7. Gastrointestinal obstruction 8. Allergy to study drugs 9. Toxic colitis 10. Not able to split the dose of bowel preparations to be used 11. Contraindication to bowel preparation 12. Risk for aspiration 13. Risk of severe cardiac arrhythmias

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Francisco C. Ramirez, M.D., MD – Mayo Clinic
  • Overall Official(s)
    • Francisco Ramirez, MD, Principal Investigator, Mayo Clinic

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.