Diagnosis of Functional Defecation Disorders in Childhood

NCT ID: NCT00230360

Last Updated: 2007-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Constipation Fecal Incontinence

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Principal Investigators

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Iben M Jonsson, Med Student

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Soren Rittig, MD

Role: STUDY_DIRECTOR

University of Aarhus

Locations

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Department of Pediatrics, Aarhus University Hospital, Skejby Sygehus

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AU-20050020

Identifier Type: -

Identifier Source: org_study_id

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