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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Diagnostic, Screening Active Not specified Other CCFL-8964 NCT00687830

Trial Description

Summary

The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The convention regime of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of the day of the colonoscopy. However, both the regimes will be for afternoon colonoscopies only. As there is a longer period between taking the evening prep (5-9PM) and the afternoon (next day 1-4PM) procedure, the morning prep is hypothesized to have better colon cleansing effect than the evening prep.

Further Study Information

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 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Cleveland Clinic Florida

Shibu Varughese, M.D.

Principal Investigator

Shibu Varughese, M.D.		Ph: 718-619-0037
		Email: VARUGHS@ccf.org

Anand Raman Kumar, M.D., M.P.H.		Ph: 305-310-1238
		Email: akuma003@fiu.edu

U.S.A.
Florida
	Weston
	Cleveland Clinic Florida
		Shibu Varughese, M.D.	Principal Investigator
		Anand Raman Kumar, MD, MPH	Sub-Investigator
		Fernando Castro, MD	Sub-Investigator
		Roger Charles, MD	Sub-Investigator
		Maria Valdes, MD	Sub-Investigator
		Javier Parra, MD	Sub-Investigator
		Allison Schneider, MD	Sub-Investigator
		Andrew Ukleja, MD	Sub-Investigator
		Matt Thoma, MD	Sub-Investigator
		Tolga Erim, MD	Sub-Investigator
		German Gonzalez, MD	Sub-Investigator
		Amy George, MD	Sub-Investigator
		Manuel O Gonzalez, MD	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00687830
Information obtained from ClinicalTrials.gov on July 16, 2008