Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy. (CCF)
|ClinicalTrials.gov Identifier: NCT00687830|
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : April 11, 2016
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: Polyethylene Glycol afternoon Drug: Polyethylene Glycol morning||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official 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|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||November 2009|
Active Comparator: Polythylene Glycol (PEG) in the evening
Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy.
'Polyethylene Glycol afternoon'
Drug: Polyethylene Glycol afternoon
Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM
Other Name: GoLytely
Experimental: Polythylene Glycol (PEG) in the Morning
Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy.
'Polyethylene Glycol morning'
Drug: Polyethylene Glycol morning
Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM
Other Name: Golytely
- Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome. [ Time Frame: Within 1 hr after the colonoscopy procedure ]
- Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep. [ Time Frame: An hour before the colonoscopy procedure ]Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687830
|United States, Florida|
|Cleveland Clinic Florida|
|Weston, Florida, United States, 33331|
|Principal Investigator:||Shibu Varughese, M.D.||Cleveland Clinic Florida|