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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vikram Kotwal, John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT01765491
First received: January 7, 2013
Last updated: January 8, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 John H. Stroger Hospital:

Primary Outcome Measures:
  • To compare the efficacy of colonoscopy preparation measured by the Ottawa scale [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Vikram Kotwal, MD, John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT01765491     History of Changes
Other Study ID Numbers: 11-206
Study First Received: January 7, 2013
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014