Clinical trial NCT00677508: Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
Official title: Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Fecal Incontinence
Keywords: Constipation
Fecal incontinence
Quality of life
Health related quality of life
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
name: University of South Alabama
name: Boston Children's Hospital
name: Ohio State University
name: University of Texas Southwestern Medical Center
First posted: 2008-05-14
Enrollment: 140
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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 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 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.

Primary outcomes:
measure: To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Manu Sood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Treurniet HF, Essink-Bot ML, Mackenbach JP, van der Maas PJ. Health-related quality of life: an indicator of quality of care? Qual Life Res. 1997 May;6(4):363-9. doi: 10.1023/a:1018435427116.
citation: Brooks RC, Copen RM, Cox DJ, Morris J, Borowitz S, Sutphen J. Review of the treatment literature for encopresis, functional constipation, and stool-toileting refusal. Ann Behav Med. 2000 Summer;22(3):260-7. doi: 10.1007/BF02895121.
citation: Youssef NN, Langseder AL, Verga BJ, Mones RL, Rosh JR. Chronic childhood constipation is associated with impaired quality of life: a case-controlled study. J Pediatr Gastroenterol Nutr. 2005 Jul;41(1):56-60. doi: 10.1097/01.mpg.0000167500.34236.6a.