Bowel Cleansing Clinical Trial
Official title:
Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
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.
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
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