Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
|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|
- 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 ]
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Children with constipation and fecal incontinence.
Children with constipation but without fecal incontinence.
Parents of children with constipation and/or fecal incontinence.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677508
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Manu Sood, MD||Medical College of Wisconsin|