An Evaluation of Patient Experience, Quality of Life, and Independence in Pediatric Patients with Functional Constipation Using Transanal irrigation with Navina Systems
Recruiting
- Conditions
- Constipation
- Registration Number
- NL-OMON20284
- Lead Sponsor
- Wellspect
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Children with constipation, both functional constipation based on Rome IV- criteria and constipation with an organic cause, who have been treated with transanal irrigation for at least one month.
Exclusion Criteria
For cross-sectional part: limited knowledge of Dutch language
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment success defined as at least 2 bowel movements per week and less than one episode of fecal incontinence per week at 1-month, 6-months, and latest follow-up
- Secondary Outcome Measures
Name Time Method To cross-sectionally investigate patient empowerment, treatment adherence, and health-related quality of life of children with functional constipation using TAI with a Navina system. Last, a self-developed questionnaire will be used to evaluate patient experience with the transanal irrigation system, adverse effects, and treatment independence (including time spent on bowel management and patient satisfaction).