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Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.

Phase 3
Completed
Conditions
Colon Cancer
Interventions
Drug: Polyethylene Glycol afternoon
Drug: Polyethylene Glycol morning
Registration Number
NCT00687830
Lead Sponsor
Cleveland Clinic Florida
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
136
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Polythylene Glycol (PEG) in the eveningPolyethylene Glycol afternoonBowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy. 'Polyethylene Glycol afternoon'
Polythylene Glycol (PEG) in the MorningPolyethylene Glycol morningBowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy. 'Polyethylene Glycol morning'
Primary Outcome Measures
NameTimeMethod
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.Within 1 hr after the colonoscopy procedure
Secondary Outcome Measures
NameTimeMethod
Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.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.

Trial Locations

Locations (1)

Cleveland Clinic Florida

🇺🇸

Weston, Florida, United States

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