Colon Cancer Clinical Trial
— CCFOfficial title:
A Randomized Endoscopist-blinded Clinical Trial Comparing the Bowel Cleansing Effect and Patient Tolerability of Same Day Polyethylene Glycol Bowel Preparation Regimen v Regimen Given on the Day Before Colonoscopy
Verified date | February 2012 |
Source | Cleveland Clinic Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are blinded to the randomization process.
Status | Completed |
Enrollment | 192 |
Est. completion date | November 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All patients attending the GI Clinic at CCF who are prescribed colonoscopy and are willing to get the procedure done in the afternoon. Exclusion Criteria: - Colonoscopy is contraindicated - Prior Colectomy or colon surgery. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Florida | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
Cleveland Clinic Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bowel cleansing effect as measured by the Ottawa scale: Evening v Morning | Within 1 hr after the colonoscopy procedure | No | |
Secondary | Patient satisfaction with the bowel prep: Evening v Morning | An hour before the colonoscopy procedure | No |
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