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Inflammatory Bowel DiseasesNCT02009202

Preparation Prior to Colonoscopy in Children

A study testing polyethylene glycol and picosulphate in people with Inflammatory Bowel Diseases, run by Skane University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Inflammatory Bowel Diseases
What is being tested?
polyethylene glycol and picosulphate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteSweden
Study dates
Nov 2012to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • elective colonoscopy

Who cannot join

  • not Swedish speaking

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Malmö University

    Malmö, Skåne County, SE20506

Other trials in Sweden

About this study

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.

Being tested
polyethylene glycol, picosulphate
Keywords
Colon preparation, Child
Medical subject headings
Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • polyethylene glycolDrug

  • picosulphateDrug

Study groups in NCT02009202
Study groupRoleWhat they receive
picosulphateActive comparatorPicosulphate is given orally
Receives: Drug: picosulphate
polyethylene glycolActive comparatorPolyethylene glycol is given orally
Receives: Drug: polyethylene glycol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clean colon/Ottowa scale

    "Clean colon" will be assessed when the colonoscopy is done.

    Measured: The day of colonoscopy.

Secondary outcomes (1)
  1. Patient reported outcome measures

    Patient questionnaire: 11 questions to be answered by the patients x 2. And further 2 questions the day of colonoscopy.

    Measured: The day of colonoscopy and after 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2013 (estimated)
  2. Study startNov 2012
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02009202
Sponsor's protocol ID
HS60-12/567
Status last verified
May 2015
First submitted
28 Nov 2013
Last updated
19 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26360658

Questions about this trial

What is this clinical trial studying?

A study testing polyethylene glycol and picosulphate in people with Inflammatory Bowel Diseases, run by Skane University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clean colon/Ottowa scale (time frame: The day of colonoscopy.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02009202, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.

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