Diagnosis of Functional Defecation Disorders in Childhood | NCT00230360

Studies
Diagnosis of Functional Defecation Disorders in Childhood

NCT00230360

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Feb 2, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Constipation
Fecal Incontinence

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Sep 29, 2005

First Submission Date that Met QC Criteria

Sep 29, 2005

First Posted Date

Sep 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2007

Last Update Posted Date

Feb 2, 2007Estimated

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iben M Jonsson, Med Student	University of Aarhus	Principal Investigator
Soren Rittig, MD	University of Aarhus	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics, Aarhus University Hospital, Skejby Sygehus		Aarhus		8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation
D005242	Fecal Incontinence
D004194	Disease

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012002	Rectal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided