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Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00380497
Recruitment Status : Completed
First Posted : September 26, 2006
Last Update Posted : July 29, 2013
Sponsor:
Information provided by (Responsible Party):
Simon Ling, The Hospital for Sick Children

Brief Summary:
The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before colonoscopy in children, and to compare effectiveness.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: PEG-Lyte® Drug: Pico-Salax® Phase 4

Detailed Description:
Good bowel cleanout before colonoscopy is commonly associated with significant discomfort that children do not tolerate well. Many pediatric centers in North America use Poly-Ethylene Glycol and electrolyte solution (PEG-ELS, Golytely®) for bowel lavage administered in a large volume, often causing nausea, vomiting and bloating. This is often poorly tolerated by children who usually require the insertion of a nasogastric tube and a day admission. Recently, Pico-Salax was approved in Canada for bowel cleanout in children. It is administered in two divided doses, each in one cup of water; it is palatable and does not have to be given in hospital. However, no controlled study in children compared it with the current standard of care. Our preliminary experience and previous literature suggest that it is effective and well tolerated. We propose to study whether colon cleanout for colonoscopy with Pico-Salax is better tolerated than Golytely in children, by a single blinded randomized controlled trial. Positive results of this study will facilitate a better tolerated regimen for bowel clean out in children.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in children-a Single Blinded Randomized Controlled Trial
Study Start Date : September 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Pico-Salax Drug: Pico-Salax®
Active Comparator: PEGlyte Drug: PEG-Lyte®



Primary Outcome Measures :
  1. Patient's satisfaction from the regimen as assessed by a questionnaire completed by the child and parents

Secondary Outcome Measures :
  1. Cleanout effectiveness (measured by: rating of a blinded gastroenterologist, the need for enema supplement, procedure length and whether the planned destination was reached
  2. Side effects (measured by: dehydration assessment, questionnaires completed by the nurse and the patient, and blood tests)


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children between 4 and 18 years of age
  • Undergoing full elective ambulatory colonoscopy

Exclusion Criteria:

  • Evidence of bowel obstruction, prior partial or total colectomy and significant renal failure (GFR<50 mls/min/1.73 m2)
  • Second dose of Pico-Salax will not be given to children with blood pressure less than the tenth percentile or pulse rate >90th% of normal reference value for age, or in children with a clinical need for bolus IV fluids decided by the clinical fellow

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380497


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Simon Ling, MD The Hospital for Sick Children, Toronto Canada
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Responsible Party: Simon Ling, Staff Gastroenterologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00380497    
Other Study ID Numbers: 1000008846
First Posted: September 26, 2006    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013
Keywords provided by Simon Ling, The Hospital for Sick Children:
Pediatrics
Colonoscopy
Bowel cleanout
Poly-Ethylene Glycol
Pico-Salax