Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients
Comparison of Morning-only With Split-dose Polyethylene Glycol for Colonoscopy Preparation in Hospitalized Patients: A Randomized Controlled Non-Inferiority Study
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 7, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedJune 18, 2023
June 1, 2023
3 months
January 7, 2013
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the efficacy of colonoscopy preparation measured by the Ottawa scale
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.
Day of procedure
Secondary Outcomes (2)
Patient compliance
Day of procedure
Patient tolerance
Same day
Study Arms (2)
Morning-only polyethylene glycol
EXPERIMENTALOne gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy.
Split-dose polyethylene glycol
ACTIVE COMPARATORHalf 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.
Interventions
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
One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy
Eligibility Criteria
You may qualify if:
- Adult patients scheduled to undergo diagnostic colonoscopy during hospitalization
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Study Officials
- STUDY DIRECTOR
Bashar Attar, MD, PhD
Cook County Health & Hospitals System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 7, 2013
First Posted
January 10, 2013
Study Start
August 1, 2012
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
June 18, 2023
Record last verified: 2023-06