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An Evaluation of Patient Experience, Quality of Life, and Independence in Pediatric Patients with Functional Constipation Using Transanal irrigation with Navina Systems

An Evaluation of Patient Experience, Quality of Life, and Independence in Pediatric Patients with Functional Constipation Using Transanal irrigation with Navina Systems

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20284
Enrollment
30
Registered
2021-08-25
Start date
2021-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Interventions

Questionnaires

Sponsors

Wellspect
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: For cross-sectional part: limited knowledge of Dutch language

Design outcomes

Secondary

MeasureTime frame
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).

Primary

MeasureTime frame
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

Contacts

Public ContactDesiree Baaleman

Amsterdam UMC

d.f.baaleman@amsterdamumc.nl0031205669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)