Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Colon capsule endoscopy is a new technology that is a noninvasive method of examining the
large bowel. The bowel preparation required for this test differs from colonoscopy in that it
needs to clean the colon but also needs to provide propulsion. Most published studies have
used medications as part of their regime that are not available in parts of North America
(ex. sodium phosphate) and have shown poor test completion, bowel preparation and polyp
detection rates.
Objective: In this study a bowel preparation for the colon capsule is proposed that uses
medications approved for use in Canada that may provide a better preparation quality and
better completion rates.
Methods: Patients who are being referred for a colonoscopy will be recruited to participate
in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel
preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four
days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3) Prucalopride
2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon capsule study.
The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or approx 4hrs prior
to procedure time and return for a colonoscopy. The colon capsule results will be reviewed by
two endoscopists experienced in video capsule endoscopy who will assess the bowel preparation
using a previously defined scale and examine for polyps. We propose that administering
Prucalopride daily for 4 days will increase intestinal motility and improve colon capsule
completion rates and a booster dose of Picosalax will improve colon capsule completion rates
compared to prucalopride by itself.