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

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Completed

CT.gov ID

NCT00677508

Collaborator

Takeda Pharmaceuticals North America, Inc. (Industry), University of South Alabama (Other), Boston Children's Hospital (Other), Ohio State University (Other), University of Texas Southwestern Medical Center (Other)

140

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation 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 incontinence). This condition often gives rise to behavioral, social, and emotional problems.

We plan to develop a disease-specific instrument to assess HRQoL in children with constipation and fecal incontinence. We hypothesize that HRQoL is worse in children with fecal incontinence compared to children with constipation but no fecal incontinence. The instrument will involve both parent and child self-reporting measures and will enable researchers to evaluate how disease and treatment strategies impact both child and parent perceptions of quality of life. In the long run this will enable physicians to develop a child friendly approach to management of chronic constipation and fecal incontinence.

Study Design

Study Type:

Observational

Actual Enrollment :

140 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
C FR Children with constipation and fecal incontinence.
C Children with constipation but without fecal incontinence.
P-C FR Parents of children with constipation and/or fecal incontinence.

Outcome Measures

Primary Outcome Measures

To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Age 2-18 years
Child and parents fluent in English
Child must meet one of the following criteria;

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

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.

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.