Improving Bowel Preparation for the Colon Capsule

This study has been completed.
Sponsor:
Collaborator:
Gastrointestinal Diseases Research Unit
Information provided by (Responsible Party):
Lawrence Hookey, Queen's University
ClinicalTrials.gov Identifier:
NCT01655095
First received: July 30, 2012
Last updated: May 25, 2013
Last verified: May 2013
  Purpose

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 2L 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.


Condition Intervention Phase
Quality of Bowel Preparation for the Colon Capsule
Colon Capsule Completion Rates
Colon Capsule Polyp Detection
Drug: PEG
Drug: Prucalopride
Drug: Picosalax
Drug: Bisacodyl
Procedure: Colon capsule
Procedure: Colonoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Improving Bowel Preparation for the Colon Capsule: Picosalax and Prucalopride vs. PEG and Prucalopride

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Assessment of the Quality of the Bowel Preparation using a previously defined scale. [ Time Frame: 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) ] [ Designated as safety issue: No ]

    Cleansing Scale:

    • Poor: Mucosa obscured by opaque debris or turbid fluid
    • Fair: Portion of the mucosa obscured by turbid fluid and/or debris preventing visualization of polyps >5mm in size
    • Good: Fluid was clear and small pieces of debris not obscuring polyps >5mm
    • Excellent: Fluid was clear and either free of debris or only small pieces

    Bubble effect scale:

    • Significant: Bubbles interfere with the examination, >10% surface area obscured by bubbles.
    • Insignificant: No bubbles or bubbles that do not interfere with the examination, <10% of surface area obscured by bubbles.

  • Number of individuals who have a complete colon capsule study (ie. pass the colon capsule prior to colonoscopy) [ Time Frame: Assessed during the time of colon capsule image review ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of patient tolerance of the bowel preparations. [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Survey questionnaire to be completed by participants at the time of the colon capsule endoscopy assessing the tolerability of the preparation and side effects.

  • Gastric emptying and small and large bowel transit time [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Determining the amount of time was required for the capsule to transit through the stomach, small bowel and large bowel for the two different preparations based on the images collected during the study.

  • Comparison of accurate identification of mucosal changes (ie. inflammation) and polyp detection with colonoscopy. [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Abnormalities identified at the time the colon capsule images are reviewed will be compared to the abnormalities identified during the time of colonoscopy documented in the colonoscopy report.


Enrollment: 20
Study Start Date: July 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG and Prucalopride Drug: PEG
PEG 2L at 1800hrs the night before the test and 2L at 0500hrs the morning of the test.
Drug: Prucalopride
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.
Procedure: Colon capsule
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.
Procedure: Colonoscopy
At 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy.
Experimental: Picosalax and Prucalopride Drug: Prucalopride
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.
Drug: Picosalax
One sachet at 1800hrs the night before the test One sachet at 0500hrs the day of the test
Drug: Bisacodyl
Bisacodyl 10mg in the evening three nights before the procedure and 10mg again two nights before the procedure.
Procedure: Colon capsule
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.
Procedure: Colonoscopy
At 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 INR>2)
  • History of serious arrhythmia
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655095

Locations
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada
Sponsors and Collaborators
Queen's University
Gastrointestinal Diseases Research Unit
Investigators
Principal Investigator: Lawrence Hookey Queens University
Study Director: Darlene Brady Queens University
  More Information

No publications provided

Responsible Party: Lawrence Hookey, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT01655095     History of Changes
Other Study ID Numbers: DMED-1478-12
Study First Received: July 30, 2012
Last Updated: May 25, 2013
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Colon capsule
Picosalax
PEG
Prucalopride

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014