Status:
COMPLETED
Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
University of South Alabama
Conditions:
Constipation
Fecal Incontinence
Eligibility:
All Genders
2-18 years
Brief Summary
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.
Detailed Description
Chronic constipation is a common problem in childhood, accounting for almost 3% of consultations in pediatric practice. In many children constipation is accompanied by overflow soiling (fecal incontin...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00677508
Start Date
September 1 2005
End Date
August 1 2011
Last Update
April 30 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226