Diagnosis of Functional Defecation Disorders in Childhood
|First Received Date ICMJE||September 29, 2005|
|Last Updated Date||February 1, 2007|
|Start Date ICMJE||June 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00230360 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Diagnosis of Functional Defecation Disorders in Childhood|
|Official Title ICMJE||Diagnosis of Functional Defecation Disorders in Childhood|
|Brief Summary||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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||April 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||4 Years to 12 Years (Child)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Denmark|
|Removed Location Countries|
|NCT Number ICMJE||NCT00230360|
|Other Study ID Numbers ICMJE||AU-20050020|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Aarhus|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Aarhus|
|Verification Date||February 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP