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Diagnosis of Functional Defecation Disorders in Childhood

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00230360
First received: September 29, 2005
Last updated: February 1, 2007
Last verified: February 2007
History of Changes

September 29, 2005
February 1, 2007
June 2005
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Complete list of historical versions of study NCT00230360 on ClinicalTrials.gov Archive Site
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Diagnosis of Functional Defecation Disorders in Childhood
Diagnosis of Functional Defecation Disorders in Childhood

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

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.
Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
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  • Constipation
  • Fecal Incontinence
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2006
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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
Both
4 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00230360
AU-20050020
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University of Aarhus
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Principal Investigator: Iben M Jonsson, Med Student University of Aarhus
Study Director: Soren Rittig, MD University of Aarhus
University of Aarhus
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP