Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy. (CCF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT00687830
First received: May 28, 2008
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Colon Cancer
Drug: Polythylene Glycol
Drug: Polyethylene glycol
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:
  • Bowel cleansing effect as measured by the Ottawa scale: Evening v Morning [ Time Frame: Within 1 hr after the colonoscopy procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction with the bowel prep: Evening v Morning [ Time Frame: An hour before the colonoscopy procedure ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: February 2008
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evening
Bowel prep given in the evening prior to the day of the afternoon colonoscopy
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
Other Name: GoLytely
Drug: 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
Other Name: PEG
Experimental: Morning
Bowel prep given on the morning of the day of the afternoon colonoscopy
Drug: 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
Other Name: PEG
Drug: 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.
Other Name: PEG

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687830

Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
Cleveland Clinic Florida
Investigators
Principal Investigator: Shibu Varughese, M.D. Cleveland Clinic Florida
  More Information

No publications provided

Responsible Party: Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT00687830     History of Changes
Other Study ID Numbers: CCFL-8964
Study First Received: May 28, 2008
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cleveland Clinic Florida:
Afternoon colonoscopy
Morning
Evening
Bowel Preparation
Efficacy
Satisfaction

ClinicalTrials.gov processed this record on October 21, 2014