Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients
This study has been completed.
Sponsor:
John H. Stroger Hospital
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
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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
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 May 22, 2013