Clinical trial NCT01582659: Outpatient Treatment of Constipation in Children
Official title: Outpatient Treatment of Constipation in Children - a Randomized Interventions Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: constipation
children
outpatient
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2012-04-20
Enrollment: 239
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constipation is a condition often seen in children. Constipation is often associated with impaired quality of life of the child and of great concern among parents. Despite the fact that both diagnosis and treatment is a simple task, it is often seen that the treatment fails, and many children are referred to a pediatric ward for specialized treatment.

There is currently little research on the subject and treatment is therefore based on expert knowledge rather than scientific research.

The study objective is to identify the most effective and least stressful treatment of children with constipation for both families and the health care system.

The following will be tested:

Does treatment of constipation in children require specialized knowledge and extensive resources or can the treatment be simplified?

The results from this study are expected to form the basis for a evidence based treatment of children with constipation.


Eligibility criteria: Inclusion Criteria:

* Children between 2 and 16 years and referral to our out patient clinic with either constipation or fecal incontinence.
* Patients must fulfill the Rome III criteria of constipation, which mean they must have at least 2 of the following characteristics: fewer than 3 bowel movements weekly, more than 1 episode of fecal incontinence weekly, large stools in the rectum by digital rectal examination or palpable on abdominal examination, occasional passing of large stools, display of retentive posturing and withholding behavior, and painful defecation.

Exclusion Criteria:

* Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
* Children receiving drugs known to affect bowel function during a 2 month period before initiation.

Primary outcomes:
measure: Treatment recovery
timeFrame: 1 year
Secondary outcomes:
measure: Usage of laxative.
timeFrame: 1 year
measure: Telephone contacts
timeFrame: 1 year
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Line Modin
city: Kolding
country: Denmark
facility: Pediatric department, Kolding Hospital
Study officials:
affiliation: Kolding
name: Marianne Jakobsen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kolding
name: Poul Erik Kofoed, MD. PHD
role: STUDY_CHAIR
affiliation: Kolding
name: Line Modin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Modin L, Walsted AM, Rittig CS, Hansen AV, Jakobsen MS. Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):594-9. doi: 10.1097/MPG.0000000000000974.