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
Overview
- Phase
- Phase 3
- Intervention
- Polyethylene Glycol afternoon
- Conditions
- Colon Cancer
- Sponsor
- Cleveland Clinic Florida
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as "Golytely" will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel preparation. For the afternoon colonoscopies, the conventional PEG regimen given on the evening prior to the day of the colonoscopy will be compared with the novel PEG regimen given on the morning of the day of the colonoscopy. The comparison will be drawn for two measures - bowel cleansing effect measured from the questionnaire given to the gastroenterologists performing the colonoscopy and the patient tolerability evaluated from the information gathered from the patient's questionnaire.
Investigators
Eligibility Criteria
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.
Arms & Interventions
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'
Intervention: Polyethylene Glycol afternoon
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'
Intervention: Polyethylene Glycol morning
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.(An hour before the colonoscopy procedure)