Preparation Prior to Colonoscopy in Children
Primary Purpose
Inflammatory Bowel Diseases
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
polyethylene glycol
picosulphate
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Colon preparation, Child
Eligibility Criteria
Inclusion Criteria:
- elective colonoscopy
Exclusion Criteria:
- not Swedish speaking
Sites / Locations
- Malmö University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
picosulphate
polyethylene glycol
Arm Description
Picosulphate is given orally
Polyethylene glycol is given orally
Outcomes
Primary Outcome Measures
Clean colon/Ottowa scale
"Clean colon" will be assessed when the colonoscopy is done.
Secondary Outcome Measures
Patient reported outcome measures
Patient questionnaire: 11 questions to be answered by the patients x 2. And further 2 questions the day of colonoscopy.
Full Information
NCT ID
NCT02009202
First Posted
November 28, 2013
Last Updated
May 18, 2015
Sponsor
Skane University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02009202
Brief Title
Preparation Prior to Colonoscopy in Children
Official Title
Preparation Prior to Colonoscopy in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skane University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Colon preparation, Child
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
picosulphate
Arm Type
Active Comparator
Arm Description
Picosulphate is given orally
Arm Title
polyethylene glycol
Arm Type
Active Comparator
Arm Description
Polyethylene glycol is given orally
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol
Intervention Type
Drug
Intervention Name(s)
picosulphate
Primary Outcome Measure Information:
Title
Clean colon/Ottowa scale
Description
"Clean colon" will be assessed when the colonoscopy is done.
Time Frame
The day of colonoscopy.
Secondary Outcome Measure Information:
Title
Patient reported outcome measures
Description
Patient questionnaire: 11 questions to be answered by the patients x 2. And further 2 questions the day of colonoscopy.
Time Frame
The day of colonoscopy and after 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective colonoscopy
Exclusion Criteria:
not Swedish speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Idvall, Professor
Organizational Affiliation
Malmö University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malmö University
City
Malmö
State/Province
Skåne
ZIP/Postal Code
SE20506
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26360658
Citation
Vejzovic V, Wennick A, Idvall E, Agardh D, Bramhagen AC. Polyethylene Glycol- or Sodium Picosulphate-Based Laxatives Before Colonoscopy in Children. J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):414-9. doi: 10.1097/MPG.0000000000000978.
Results Reference
derived
Learn more about this trial
Preparation Prior to Colonoscopy in Children
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