We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diagnosis of Functional Defecation Disorders in Childhood

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00230360
First Posted: September 30, 2005
Last Update Posted: February 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Aarhus
  Purpose
Purpose To compare different kinds of diagnostic investigations in order to identify the most sensitive and least invasive when diagnosing constipation.

Condition
Constipation Fecal Incontinence

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Diagnosis of Functional Defecation Disorders in Childhood

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Estimated Enrollment: 90
Study Start Date: June 2005
Estimated Study Completion Date: April 2006
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230360


Locations
Denmark
Department of Pediatrics, Aarhus University Hospital, Skejby Sygehus
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Iben M Jonsson, Med Student University of Aarhus
Study Director: Soren Rittig, MD University of Aarhus
  More Information

ClinicalTrials.gov Identifier: NCT00230360     History of Changes
Other Study ID Numbers: AU-20050020
First Submitted: September 29, 2005
First Posted: September 30, 2005
Last Update Posted: February 2, 2007
Last Verified: February 2007

Keywords provided by University of Aarhus:
constipation
fecal incontinence
diagnosis
children

Additional relevant MeSH terms:
Constipation
Fecal Incontinence
Signs and Symptoms, Digestive
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases


To Top