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Clinical Trials/NCT00677508
NCT00677508CompletedNot Applicable

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

Medical College of Wisconsin1 site in 1 country140 target enrollmentStarted: September 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
140
Locations
1
Primary Endpoint
To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 2 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Manu Sood

Chief, Associate Professor

Medical College of Wisconsin

Study Sites (1)

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