- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02009202
Preparation Prior to Colonoscopy in Children
Colonoscopy is a routinely performed examination of children and adolescents in the diagnostic process of inflammatory bowel disease (IBD). It is necessary that the bowel is clean so the colonoscopy can be optimally performed. The cleansing of the bowel by means of laxatives prior to the examination is, however, considered difficult by many children. Getting smaller children to cooperate and to drink a substantial volume of laxative fluid prior to the examination can be particularly difficult. There are several possible cleansing procedures and combinations of procedures for the cleansing of the colon, for example by means of polyethylene glycol and sodium picosulphate, which are the two most commonly used methods. Cleansing by means of polyethylene glycol can, due to the necessary intake of a substantial quantity of fluid, be particularly frustrating for patients. Often the only way to carry out the preparation is with the insertion of a nasogastric tube, which can cause discomfort for some children. Cleansing the colon by means of sodium picosulphate, which involves an intake of a small quantity of fluid, has been suggested to be a good sufficient method resulting with a satisfactory result in terms of bowel cleanliness. However, studies have so far encompassed only a smaller number of children and further studies are needed to confirm that there is no difference between the two methods in terms of resultant bowel cleanliness.
The purpose of this randomized controlled study is to compare preparation by means of polyethylene glycol and preparation with sodium picosulphate prior to colonoscopy in children.
One hundred children scheduled for colonoscopy in southern Sweden will be randomized into either patient group 1 (for preparation with polyethylene glycol) or patient group 2 (for preparation with sodium picosulphate). For the random sampling, data-driven selection will be implemented. A CONSORT Flowchart (2012) will be encompassed by the study. To assess the cleanliness of the intestinal tract (and volume of fluid in the intestine), the Ottawa Scale will be used (Rostom & Jolicoeur, 2009). All colonoscopy examinations will be performed by the same paediatric gastroenterologist, to whom no information about which preparation method was used by each child will be disclosed. Furthermore, the gastroenterologist will, meet with the children first after the investigation has been completed. All information regarding the investigation will be given to the patient by the admitting physician. During the colonoscopy the gastroenterologist will evaluate the intestinal cleanliness and submit the reports in sealed coded envelopes to the nurse in charge of the patient.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Skåne
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Malmö, Skåne, Sweden, SE20506
- Malmo university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- elective colonoscopy
Exclusion Criteria:
- not Swedish speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: picosulphate
Picosulphate is given orally
|
|
ACTIVE_COMPARATOR: polyethylene glycol
Polyethylene glycol is given orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clean colon/Ottowa scale
Time Frame: The day of colonoscopy.
|
"Clean colon" will be assessed when the colonoscopy is done.
|
The day of colonoscopy.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient reported outcome measures
Time Frame: The day of colonoscopy and after 1 week
|
Patient questionnaire: 11 questions to be answered by the patients x 2. And further 2 questions the day of colonoscopy.
|
The day of colonoscopy and after 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ewa Idvall, Professor, Malmo university
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS60-12/567
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