ConstipationNCT00230360
Diagnosis of Functional Defecation Disorders in Childhood
An observational study of Constipation and Fecal Incontinence, run by University of Aarhus at 1 site in Denmark.
Trial summary
Purpose To compare different kinds of diagnostic investigations in order to identify the most sensitive and least invasive when diagnosing constipation. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Fecal Incontinence
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2005to Apr 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Referred children
- functional constipation and/or fecal incontinence
- Healthy children
- No sign of functional constipation and/or fecal incontinence
Who cannot join
- Referred children
- organic constipation/ fecal incontinence
- Healthy children
- constipation/ fecal incontinence
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Pediatrics, Aarhus University Hospital, Skejby Sygehus
Aarhus, 8200
About this study
Purpose To compare different kinds of diagnostic investigations in order to identify the most sensitive and least invasive when diagnosing constipation.
Read the detailed description
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
- Constipation, Fecal Incontinence
- Keywords
- constipation, fecal incontinence, diagnosis, children
- Medical subject headings
- Constipation, Fecal Incontinence, Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startJun 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Iben M Jonsson, Med Student, Principal investigator, University of AarhusSoren Rittig, MD, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230360
- Sponsor's protocol ID
- AU-20050020
- Status last verified
- Feb 2007
- First submitted
- 29 Sep 2005
- Last updated
- 2 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Functional Defecation Disorders in Childhood
- ClinicalTrials.gov ID
- NCT00230360
- Acronym / sponsor ID
- AU-20050020
- Conditions
- Constipation, Fecal Incontinence
- Keywords
- constipation, fecal incontinence, diagnosis, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Apr 2006
- First posted
- 30 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose To compare different kinds of diagnostic investigations in order to identify the most sensitive and least invasive when diagnosing constipation.
Detailed description
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Referred children
- functional constipation and/or fecal incontinence
- Healthy children
- No sign of functional constipation and/or fecal incontinence
Key exclusion criteria (4 listed)
- Referred children
- organic constipation/ fecal incontinence
- Healthy children
- constipation/ fecal incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2007.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iben M Jonsson, Med Student principal investigator
University of Aarhus
Soren Rittig, MD study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Fecal Incontinence, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2007.