- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01695915
Diurnal Variation in Rectal Diameter
Diurnal Variation in Rectal Diameter Measured by Transabdominal Ultrasound in Healthy and Constipated Children.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Kolding, Denemarken, 6000
- Pediatric department, Kolding Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Constipated children are recruited from the outpatient clinic at Kolding pediatric department. A list of patients which have been given the diagnose constipation are drawn from the computer and reviewed. Children between 4-12 years who fulfill the Rome III criteria of constipation and have been taking PEG maintenance treatment at least 1 month, are contacted by telephone for possible participation in the study.
Healthy participants without constipation or other diseases affecting the gastrointestinal tract were recruited among the employees of the Department of Pediatrics at Kolding Hospital.
Written informed consent was obtained from both parents before any procedures were initiated.
Beschrijving
Constipated Inclusion Criteria:
- Children from 4 to 12 years with previously diagnosed simple constipation defined by ROME III criteria, which at inclusion is in maintenance therapy with PEG + E and has been in treatment for at least 1 month.
Exclusion Criteria:
- Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
- Children receiving drugs known to affect bowel function during a 2 month period before initiation besides laxatives.
Healthy inclusion Criteria:
- Children between 4 and 12 years of age.
Healthy exclusion Criteria:
- Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
- Children receiving drugs known to affect bowel function during a 2 month period before initiation.
- Children with a previous history of constipation, fecal incontinence and / or urinary tract infections.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Healthy
Transabdominal ultrasound
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Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.
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Constipated
Transabdominal ultrasound
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Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Rectal diameter
Tijdsspanne: 24 hours
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24 hours
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Line Modin, MD, Kolding Sygehus
- Studie directeur: Marianne Jakobsen, MD, phd, Kolding Sygehus
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DV-Rect-UL
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