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Completed

NCT Number: 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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malmö University

Malmö, Skåne County, SE20506, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective colonoscopy

Exclusion criteria

  • not Swedish speaking

Treatment and study plan

Polyethylene glycol

Drug

picosulphate

Drug

Primary outcomes

  1. Clean colon/Ottowa scale

    Time frame: The day of colonoscopy.

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2013
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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