NCT00687830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

April 11, 2016

Completed
Last Updated

May 17, 2017

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

May 28, 2008

Results QC Date

February 19, 2015

Last Update Submit

April 17, 2017

Conditions

Colon Cancer

Keywords

Afternoon colonoscopyMorningEveningBowel PreparationEfficacySatisfaction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.

    An hour before the colonoscopy procedure

Study Arms (2)

Polythylene Glycol (PEG) in the evening

ACTIVE COMPARATOR

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

Drug: Polyethylene Glycol afternoon

Polythylene Glycol (PEG) in the Morning

EXPERIMENTAL

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

Drug: Polyethylene Glycol morning

Interventions

Polyethylene Glycol afternoonDRUG

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

Also known as: GoLytely
Polythylene Glycol (PEG) in the evening
Polyethylene Glycol morningDRUG

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

Also known as: Golytely
Polythylene Glycol (PEG) in the Morning

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients attending the GI Clinic at CCF who are prescribed colonoscopy and are willing to get the procedure done in the afternoon.

You may not qualify if:

  • Colonoscopy is contraindicated
  • Prior Colectomy or colon surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (1)

  • 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.

    PMID: 20606677RESULT

Related Links

MeSH Terms

Conditions

Colonic NeoplasmsPersonal Satisfaction

Interventions

Golytely

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBehavior

Results Point of Contact

Title
Dr. Shibu Varughese and Dr. Anand Kumar
Organization
Cleveland Clinic Florida
akuma003@fiu.edu
305-310-1238

Study Officials

  • Shibu Varughese, M.D.

    Cleveland Clinic Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 2, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

May 17, 2017

Results First Posted

April 11, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)