Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
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|ClinicalTrials.gov Identifier: NCT00677508|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2008
Last Update Posted : March 15, 2018
|Condition or disease|
|Constipation 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.
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|Official Title:||Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling|
|Actual Study Start Date :||September 2005|
|Actual Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||January 2019|
Children with constipation and fecal incontinence.
Children with constipation but without fecal incontinence.
Parents of children with constipation and/or fecal incontinence.
- To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677508
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Manu Sood, MD||Medical College of Wisconsin|