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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677508
• Other study ID #: CHW 05/154
• Status: Completed
• Start date: September 2005
• Est. completion date: August 2011

Study information

• Verified date: April 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Fecal Incontinence

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (6)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Boston Children’s Hospital, Ohio State University, Takeda Pharmaceuticals North America, Inc., University of South Alabama, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence.		2 years