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: March 11, 2016
Last verified: February 2016
  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: Polyethylene Glycol afternoon
Drug: Polyethylene Glycol morning
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:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep. [ Time Frame: An hour before the colonoscopy procedure ] [ Designated as safety issue: No ]
    Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.


Enrollment: 136
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
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

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

Additional Information:
Publications:
Responsible Party: Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT00687830     History of Changes
Other Study ID Numbers: CCFL-8964 
Study First Received: May 28, 2008
Results First Received: February 19, 2015
Last Updated: March 11, 2016
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 May 26, 2016