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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Takeda Pharmaceuticals North America, Inc.
University of South Alabama
Children's Hospital Boston
Ohio State University
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Manu Sood, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00677508
First received: May 9, 2008
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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
Constipation
Fecal Incontinence

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: September 2005
Estimated Study Completion Date: December 2015
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children will be recruited from the Constipation Clinic at Children's Hospital of Wisconsin, as well as four coolaborating sites.

Criteria

Inclusion criteria:

  1. Age 2-18 years
  2. Child and parents fluent in English
  3. 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):

  1. Two or fewer defecations in the toilet per week
  2. At least 1 episode of fecal incontinence per week
  3. History of retentive posturing or excessive volitional stool retention
  4. History of painful or hard bowel movements
  5. Presence of a large fecal mass in the rectum
  6. 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:

  1. 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
  2. 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]:

  1. Defecation into places inappropriate to the social context at least once per month.
  2. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms
  3. No evidence of fecal retention.

Exclusion criteria:

  1. Children with developmental delays and children over 12 years of age who are unable to understand the questionnaires.
  2. 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.
  3. Child and parents not fluent in English.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00677508

Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Takeda Pharmaceuticals North America, Inc.
University of South Alabama
Children's Hospital Boston
Ohio State University
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Manu Sood, MD Medical College of Wisconsin
  More Information

Publications:
Responsible Party: Manu Sood, Chief, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00677508     History of Changes
Other Study ID Numbers: CHW 05/154
Study First Received: May 9, 2008
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Constipation
Fecal incontinence
Quality of life
Health related quality of life

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

ClinicalTrials.gov processed this record on October 22, 2014