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…
ID
Bron
Verkorte titel
Aandoening
Constipation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Retrospective part: baseline, 1 month follow-up, 6 month follow-up, and latest follow-up. Cross-sectional: single time point.
Onderzoeksproduct en/of interventie
Questionnaires
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
For cross-sectional part: limited knowledge of Dutch language
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9691 |
| Ander register | Medical Ethics Review Committee AMC : W21_240 # 21.267 |