No registrations found.
ID
Source
Brief title
Health condition
Constipation
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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).
Background summary
The objective of our study is to retrospectively investigate the clinical effectiveness of children with constipation using a Navina transanal irrigation (TAI) system. Secondary objective is to cross-sectionally investigate patient empowerment and treatment independence and their relation with health- related quality of life and treatment adherence in pediatric patients with constipation treated with TAI. In addition, we will assess patient use, patient experience and the safety of the device.
Study objective
With this study we expect to generate important knowledge about treatment experience, treatment adherence, and quality of life of children using TAI with a Navina system. If we can identify factors that affect either one of those, pediatric healthcare professionals may be able to adjust their approach or therapy accordingly. We hypothesize that the health-related quality of life of children with constipation using TAI is lower compared to children with constipation in general and may be affected by the experienced patient empowerment and treatment independence. We hypothesize that treatment adherence of children treated with TAI is higher compared to children only treated with laxatives.
Study design
Retrospective part: baseline, 1 month follow-up, 6 month follow-up, and latest follow-up. Cross-sectional: single time point.
Intervention
Questionnaires
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9691 |
| Other | Medical Ethics Review Committee AMC : W21_240 # 21.267 |