Diagnosis of Functional Defecation Disorders in Childhood

Constipation Clinical Trial

Official title:

Diagnosis of Functional Defecation Disorders in Childhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230360
• Other study ID #: AU-20050020
• Status: Completed
• Phase: N/A
• First received: September 29, 2005
• Last updated: February 1, 2007
• Start date: June 2005
• Est. completion date: April 2006

Study information

• Verified date: February 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Constipation
• Fecal Incontinence

Locations

Country	Name	City	State
Denmark	Department of Pediatrics, Aarhus University Hospital, Skejby Sygehus	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark,