Clinical trial NCT00687830: Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Cancer
Keywords: Afternoon colonoscopy
Morning
Evening
Bowel Preparation
Efficacy
Satisfaction
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-06-02
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Within 1 hr after the colonoscopy procedure
Secondary outcomes:
measure: Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.
timeFrame: An hour before the colonoscopy procedure
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Shibu Varughese, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.