Preparation Prior to Colonoscopy in Children

NCT02009202 | Completed

• 1 other identifier: HS60-12/567
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Colon preparation; Child

Outcome Measures

Primary Outcomes (1)

• Clean colon/Ottowa scale

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

  The day of colonoscopy.

Secondary Outcomes (1)

• Patient reported outcome measures

  The day of colonoscopy and after 1 week

Study Arms (2)

picosulphate

ACTIVE COMPARATOR

Picosulphate is given orally

Drug: picosulphate

polyethylene glycol

ACTIVE COMPARATOR

Polyethylene glycol is given orally

Drug: polyethylene glycol

Interventions

polyethylene glycol DRUG

polyethylene glycol

picosulphate DRUG

picosulphate

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• elective colonoscopy

You may not qualify if:

• not Swedish speaking

Sponsors & Collaborators

• Skane University Hospital: lead

Study Sites (1)

Malmö University

Malmo, Skåne County, SE20506, Sweden

Location

Related Publications (1)

• 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.

  PMID: 26360658 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Polyethylene Glycols; picosulfate sodium

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ewa Idvall, Professor

  Malmö University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 11, 2013
• Study Start: November 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

SE (1)