- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00230360
Diagnosis of Functional Defecation Disorders in Childhood
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering
Kontakter og plasseringer
Studiesteder
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Aarhus, Danmark, 8200
- Department of Pediatrics, Aarhus University Hospital, Skejby Sygehus
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Iben M Jonsson, Med Student, University of Aarhus
- Studieleder: Soren Rittig, MD, University of Aarhus
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AU-20050020
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