Clinical trial NCT00230360: Diagnosis of Functional Defecation Disorders in Childhood
Official title: Diagnosis of Functional Defecation Disorders in Childhood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Fecal Incontinence
Keywords: constipation
fecal incontinence
diagnosis
children
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-09-30
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Purpose To compare different kinds of diagnostic investigations in order to identify the most sensitive and least invasive when diagnosing constipation.

Detailed description: Defecation disorders in children are extremely common especially constipation and fecal incontinence. International studies show that constipation make up approximately 3% of Pediatric Outpatient Clinic11 (192) and 25% of Pediatric gastroenterology consultations. Between 1,5-3% of all 4-12 year olds experience fecal incontinence.

Constipation and fecal incontinence can be extremely physical unpleasant and can have significant ramifications for a child's emotional and social functioning eg. low self esteem.

Though most agree that constipation and faecal incontinence are a considerable problem worldwide there is disagreement when it comes to a definition and diagnostic tools. Several definitions have been used. This has led to great difficulties when trying to estimate prevalence, understand and compare in order to improve different treatments.

Hypothesis:

* It is possible to diagnose constipation accurately by using a combination of anamnesis, stool diary, physical examination and transabdominal ultrasonography
* Transabdominal ultrasonography is a safe and sensitive diagnostic tool and can be used as an alternative or substitute to rectal examination.

Purpose To compare different kinds of diagnostic (tools) investigations in order to identify the most sensitive and least invasive when diagnosing constipation.

Material and methods 60 children referred to the paediatric outpatient clinic with fecal incontinence or suspicion of constipation. The investigations include anamnesis and physical examination with rectal examination and transabdominal ultrasonography. Home registration of a stool diary based on the Bristol Scale for 3 weeks thereafter a Colonic transit time is performed.

Data is compared to data from 30 healthy children that have gone through the same investigations except the CTT that is based on x-rays.

Eligibility criteria: Inclusion Criteria:

Referred children

* functional constipation and/or fecal incontinence

Healthy children

* No sign of functional constipation and/or fecal incontinence

Exclusion Criteria:

Referred children

* organic constipation/ fecal incontinence

Healthy children

* constipation/ fecal incontinence

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Pediatrics, Aarhus University Hospital, Skejby Sygehus
Study officials:
affiliation: University of Aarhus
name: Iben M Jonsson, Med Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Soren Rittig, MD
role: STUDY_DIRECTOR
References: