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

July 6, 2020 updated by: Francisco C. Ramirez, M.D., Mayo Clinic
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Golytely

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Tolerance
Time Frame: 24 hours
Percentage of participants self-reporting finishing the bowel preparation
24 hours
Cecal Intubation
Time Frame: 24 hours
Assess the success of cecal intubation rate between three bowel preparations.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Francisco Ramirez, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-003983

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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