Clinical trial NCT01655095: Improving Bowel Preparation for the Colon Capsule
Official title: Improving Bowel Preparation for the Colon Capsule: Picosalax and Prucalopride vs. PEG and Prucalopride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Quality of Bowel Preparation for the Colon Capsule
Colon Capsule Completion Rates
Colon Capsule Polyp Detection
Keywords: Colon capsule
Picosalax
PEG
Prucalopride
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Hotel Dieu Hospital (Gastrointestinal Diseases Research Unit)
First posted: 2012-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male and female patients between the ages of 18 and 75
* Patients being referred for colonoscopy

Exclusion Criteria:

* Symptoms of dysphagia
* Bowel obstruction or ileus
* Known stricture or fistula
* Inflammatory bowel disease
* Previous small or large bowel surgery
* Severe gastroparesis or motility disorder
* Renal impairment (GFR\<55 within 3 months of study)
* Congestive heart failure (NYHA III or IV)
* Ischemic heart disease
* Cirrhosis or severe hepatic dysfunction (ascites or lab result INR\>2)
* History of serious arrhythmia
* Pregnancy

Primary outcomes:
measure: Assessment of the Quality of the Bowel Preparation using a previously defined scale.
timeFrame: Assessed at the time of review of the colon capsule images (from ingestion of capsule until the capsule is passed or the battery runs out--max 10 hrs) and at the time of colonoscopy on the same day (using a previously defined scale as described)
measure: Number of individuals who have a complete colon capsule study (ie. pass the colon capsule prior to colonoscopy)
timeFrame: Assessed during the time of colon capsule image review
Secondary outcomes:
measure: Assessment of patient tolerance of the bowel preparations.
timeFrame: Assessed at the time of colon capsule ingestion (will cover time period from beginning of bowel preparation, as previously described, to ingestion of the colon capsule)
measure: Gastric emptying and small and large bowel transit time
timeFrame: Assessed at the time the colon capsule images are reviewed (will be monitored from time of capsule ingestion until capsule is expelled or battery runs out--max 10 hours)
measure: Comparison of accurate identification of mucosal changes (ie. inflammation) and polyp detection with colonoscopy.
timeFrame: Determined at the time of review of the colon capsule images (assessed from time of capsule ingestion until capsule is expelled or battery runs out--max. 10 hours) and assessed during the colonoscopy the same day.
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queens University
name: Lawrence Hookey
role: PRINCIPAL_INVESTIGATOR
affiliation: Queens University
name: Darlene Brady
role: STUDY_DIRECTOR
References: