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

NeuroTherapia, Inc.

Status and phase: Completed; Phase 3

Conditions: Colon Cancer

Treatments: Drug: Polyethylene Glycol afternoon; Drug: Polyethylene Glycol morning

Study type: Interventional

Funder types: Other

Identifiers

NCT00687830

CCFL-8964

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Polythylene Glycol (PEG) in the evening

Active Comparator group

Description:

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

Treatment:

Drug: Polyethylene Glycol afternoon

Polythylene Glycol (PEG) in the Morning

Experimental group

Description:

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

Treatment:

Drug: Polyethylene Glycol morning