Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling

Completed

Conditions studied: Constipation, Fecal Incontinence

In brief

We propose to develop parent and child disease-specific instruments to assess health related quality of life (HRQoL) in children with constipation and fecal incontinence.

Key facts

Study ID

NCT00677508

Run by

Medical College of Wisconsin

People needed

140

Starts

2005-09-01

Expected to finish

2011-08-01

Last updated by the study team

2020-04-30

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 2-18 years
• Child and parents fluent in English
• Child must meet one of the following criteria;
• A. Constipation and fecal incontinence: must include 2 or more of the following in a child with insufficient criteria for a diagnosis of IBS (criteria fulfilled at least once per week for at least 2 months before diagnosis in a child over 4 years of age and for at least one month in a child less than 4 years of age):
• Two or fewer defecations in the toilet per week
• At least 1 episode of fecal incontinence per week
• History of retentive posturing or excessive volitional stool retention
• History of painful or hard bowel movements
• Presence of a large fecal mass in the rectum
• History of large diameter stools that may obstruct the toilet
• B. Constipation predominant IBS: must include the following, once a week for at least 2 months:
• Abdominal pain/discomfort, associated with 2 of the following:
• improved with defecation
• onset associated with 2 or less stools per week
• onset associated with hard or lump stool
• no evidence of inflammatory, anatomic, metabolic or neoplastic processes.
• C. Non retentive fecal incontinence: must include all of the following in a child with a developmental age of at least 4 years (criteria fulfilled at least once per week for at least 2 months before diagnosis) [4]:
• Defecation into places inappropriate to the social context at least once per month.
• No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms
• No evidence of fecal retention.

You may not qualify if…

• Children with developmental delays and children over 12 years of age who are unable to understand the questionnaires.
• Associated chronic disease which may have an impact on quality of life such as cerebral palsy, spine deformity or malformations, learning difficulties, severe mental illness, celiac disease, etc.
• Child and parents not fluent in English.

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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