Improving Bowel Preparation for the Colon Capsule
Condition: Quality of Bowel Preparation for the Colon Capsule; Colon Capsule Completion Rates; Colon Capsule Polyp Detection
Study type: Interventional
Phase: Phase 3

Summary: 
      Colon capsule endoscopy is a technology that has been developed as a noninvasive method of
      examining the large bowel. The biggest limitation to its use has been finding a bowel
      preparation that will both clean the colon adequately for good visualization of the mucosa
      and also help propel the capsule through the colon. Most studies have been conducted in
      Europe using bowel preparation medications that are not approved for use in North America.

      The purpose of this study is to compare a combination of polyethylene glycol (PEG) and
      prucalopride to Picosalax and prucalopride to determine which regime will give a better colon
      cleanse for the colon capsule. Both PEG and Picosalax are bowel preparations that are used
      routinely for colonoscopy in Canada. Prucalopride is a new medication recently approved for
      use in Canada which improves intestinal motility and should help with colon capsule transit.

      Patients who are being referred for colonoscopy will be enrolled in the study and randomized
      to one of the bowel preparation regimes. They will undergo a split-dose bowel preparation
      with either PEG or Picosalax, which is routine for colonoscopy. As part of the standard bowel
      preparation, patients randomized to the Picosalax group will take dulcolax three nights
      before the test and then again two nights before the test. The evening before the test
      patients will take either PEG 2L or one sachet of Picosalax. The following morning they will
      take another dose of either PEG (2 Liter container) or one sachet of Picosalax. They will
      then ingest the colon capsule and a dose of Prucalopride that morning. After 7 hours they
      will return to the endoscopy unit where they will undergo a colonoscopy, which is the
      standard of care for examination of the colon.

      The images from the colon capsule will be reviewed and the quality of bowel preparation will
      be graded using a previously validated scale. It is hypothesized that the Picosalax and
      prucalopride regime will give a better cleanse for the colon than PEG and prucalopride as
      there will be less turbid fluid in the colon and allow for a better view of the mucosa. Polyp
      detection and abnormalities of the mucosa detected with the colon capsule will also be
      compared to polyps and abnormalities detected at the time of colonoscopy.
    


Intervention name(s): PEG; Prucalopride; Picosalax; Bisacodyl; Colon capsule; Colonoscopy
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): PEG 2L at 1800hrs the night before the test and 2L at 0500hrs the morning of the test.; Prucalopride 2mg will be administered at 0800hrs on the day of the test, at the same time the colon capsule is administered. Two hours later the position of the colon capsule will be assess with a Realtime Viewer. If the capsule has not reached the cecum a second dose of Prucalopride 2mg will be administered at that time.; One sachet at 1800hrs the night before the test One sachet at 0500hrs the day of the test; Bisacodyl 10mg in the evening three nights before the procedure and 10mg again two nights before the procedure.; The colon capsule will be ingested at 0800hrs the day of the test. Seven hours will be allowed for the capsule to clear the bowel. The images will be reviewed by two endoscopists with experience reading video capsule endoscopy.; At 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy.
Intervention MeSH terms: Prucalopride; Bisacodyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Colon capsule; Picosalax; PEG; Prucalopride