Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.

Colon Cancer Clinical Trial

— CCF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687830
• Other study ID #: CCFL-8964
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2008
• Last updated: February 8, 2012
• Start date: February 2008
• Est. completion date: November 2009

Study information

• 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

Clinical Trial 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.

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 information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Drug:
• Polythylene Glycol
Prescribed the standard dose of 4L or 1 Gallon to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM
• Polythylene Glycol
Prescribed the standard dose of 4L or 1 Gallon to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM
• Polyethylene glycol
Prescribed the standard dose of 4L or 1 Gallon to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM
• Polyethylene glycol
Bowel prep given on the morning of the day of the afternoon colonoscopy. Between 6AM and 10AM on the same day of colonoscopy.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cleveland Clinic Florida

Country where clinical trial is conducted

United States, 

Outcome

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