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

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ClinicalTrials.gov Identifier: NCT01978509
Recruitment Status : Terminated (Lack of enrollment)
First Posted : November 7, 2013
Results First Posted : July 17, 2020
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Francisco C. Ramirez, M.D., Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: Low volume prep (Prepopik) Drug: Moderate volume prep (Moviprep) Drug: High volume prep (Golytely) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies
Study Start Date : September 2013
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Low volume prep (Prepopik)
Low volume prep for colonoscopy (Prepopik)
 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.
Other Name: Prepopik
Active Comparator: Moderate volume prep (Moviprep)
Moderate volume prep for colonoscopy (Moviprep)
 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.
Other Name: Moviprep
Active Comparator: High volume prep (Golytely)
High volume prep for colonoscopy (Golytely)
 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.
Other Name: Golytely


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Patient Tolerance [ Time Frame: 24 hours ]
    Percentage of participants self-reporting finishing the bowel preparation

  2. Cecal Intubation [ Time Frame: 24 hours ]
    Assess the success of cecal intubation rate between three bowel preparations.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978509


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Francisco Ramirez, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Francisco C. Ramirez, M.D., Mayo Clinic:
Study Protocol  [PDF] December 3, 2015
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Francisco C. Ramirez, M.D., MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01978509    
Other Study ID Numbers: 13-003983
First Posted: November 7, 2013    Key Record Dates
Results First Posted: July 17, 2020
Last Update Posted: July 17, 2020
Last Verified: July 2020
Keywords provided by Francisco C. Ramirez, M.D., Mayo Clinic:
Colonoscopy