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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


Phase 3
N/A
N/A
Not Enrolling
Both
Colon Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Bowel cleansing effect as measured by the Ottawa scale: Evening v Morning

Outcome Time Frame:

Within 1 hr after the colonoscopy procedure

Safety Issue:

No

Principal Investigator

Shibu Varughese, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Florida

Authority:

United States: Institutional Review Board

Study ID:

CCFL-8964

NCT ID:

NCT00687830

Start Date:

February 2008

Completion Date:

November 2009

Related Keywords:

  • Colon Cancer
  • Afternoon colonoscopy
  • Morning
  • Evening
  • Bowel Preparation
  • Efficacy
  • Satisfaction
  • Colonic Neoplasms

Name

Location

Cleveland Clinic FloridaWeston, Florida  33331