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Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765491
First Posted: January 10, 2013
Last Update Posted: January 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vikram Kotwal, John H. Stroger Hospital
  Purpose

Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient preparation and colonoscopy. The aim of the investigators study is to compare the efficacy and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in hospitalized patients undergoing colonoscopy.

This is a single-center, prospective, endoscopist-blinded study in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa scale between arms. Secondary end points are patient compliance and tolerance.


Condition Intervention
Bowel Preparation for Colonoscopy Other: Split-dose polyethylene glycol Other: Morning-only polyethylene glycol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Morning-only With Split-dose Polyethylene Glycol for Colonoscopy Preparation in Hospitalized Patients: A Randomized Controlled Non-Inferiority Study

Resource links provided by NLM:


Further study details as provided by Vikram Kotwal, John H. Stroger Hospital:

Primary Outcome Measures:
  • To compare the efficacy of colonoscopy preparation measured by the Ottawa scale [ Time Frame: Day of procedure ]
    Colonoscopy was performed by gastroenterology fellows under the supervision of attending physicians and both were blinded to the type of preparation taken by the study patients. Bowel cleansing was evaluated by the Ottawa scale. Scoring of each part of the colon (right, middle and left) was done separately and the total amount of fluid was noted. The scores were then added to calculate the total score out of 14.


Secondary Outcome Measures:
  • Patient compliance [ Time Frame: Day of procedure ]
    Before the patients were taken to the endoscopy suite, they completed a questionnaire, asking the amount of preparation that was taken to evaluate compliance.

  • Patient tolerance [ Time Frame: Same day ]
    Before the patients were taken to the endoscopy suite, they completed a questionnaire to evaluate tolerance for taking the preparation. Patients were asked about side-effects like nausea, vomiting, abdominal pain and bloating.


Enrollment: 120
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morning-only polyethylene glycol
One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy.
Other: Morning-only polyethylene glycol
One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy
Active Comparator: Split-dose polyethylene glycol
Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy.
Other: Split-dose polyethylene glycol
Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients scheduled to undergo diagnostic colonoscopy during hospitalization

Exclusion Criteria:

  • Critically ill/Intensive Care Unit patients
  • Suspected bowel obstruction/perforation
  • History of colon resection
  • Patients with altered mental status/inability to provide informed consent
  • Incarcerated patients
  • Pregnant females
  Contacts and Locations
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): NCT01765491


Locations
United States, Illinois
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
Investigators
Study Director: Bashar Attar, MD, PhD Cook County Health and Hospitals System
  More Information

Responsible Party: Vikram Kotwal, MD, John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT01765491     History of Changes
Other Study ID Numbers: 11-206
First Submitted: January 7, 2013
First Posted: January 10, 2013
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by Vikram Kotwal, John H. Stroger Hospital:
colonoscopy
bowel preparation
polyethylene glycol