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

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Polyethylene Glycol afternoon
Polyethylene Glycol morning
Sponsored by
Cleveland Clinic Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Afternoon colonoscopy, Morning, Evening, Bowel Preparation, Efficacy, Satisfaction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Polythylene Glycol (PEG) in the evening

Polythylene Glycol (PEG) in the Morning

Arm Description

Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy. 'Polyethylene Glycol afternoon'

Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy. 'Polyethylene Glycol morning'

Outcomes

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.

Secondary Outcome Measures

Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.
Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.

Full Information

First Posted
May 28, 2008
Last Updated
April 17, 2017
Sponsor
Cleveland Clinic Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00687830
Brief Title
Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cleveland Clinic Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Afternoon colonoscopy, Morning, Evening, Bowel Preparation, Efficacy, Satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polythylene Glycol (PEG) in the evening
Arm Type
Active Comparator
Arm Description
Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy. 'Polyethylene Glycol afternoon'
Arm Title
Polythylene Glycol (PEG) in the Morning
Arm Type
Experimental
Arm Description
Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy. 'Polyethylene Glycol morning'
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol afternoon
Other Intervention Name(s)
GoLytely
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol morning
Other Intervention Name(s)
Golytely
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.
Description
Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.
Time Frame
An hour before the colonoscopy procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shibu Varughese, M.D.
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20606677
Citation
Varughese S, Kumar AR, George A, Castro FJ. Morning-only one-gallon polyethylene glycol improves bowel cleansing for afternoon colonoscopies: a randomized endoscopist-blinded prospective study. Am J Gastroenterol. 2010 Nov;105(11):2368-74. doi: 10.1038/ajg.2010.271. Epub 2010 Jul 6.
Results Reference
result
Links:
URL
http://www.esge.com/assets/downloads/pdfs/guidelines/2013_bowel_preparation_for_colonoscopy.pdf
Description
European society of GI endoscopy guidelines on bowel preparation. Reference 61, Page 145 : Same day regimen.

Learn more about this trial

Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.

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