(Kosten)-effectiviteit van fysiotherapie toegevoegd aan de standaard behandeling van kinderen met functionele obstipatie
Titel onderzoek Engels
OrganisatieUniversitair Medisch Centrum Groningen
Samenvatting van het onderzoek
Objectives and study: The aim of this study is to assess the effectiveness and cost-effectiveness of adding physiotherapy to conventional treatment for children with functional constipation in primary care. Physiotherapy is focusing on improving the coordination between the pelvic floor and abdominal musculature during bowel movement, while conventional treatment is mainly focusing on symptomatic relief of symptoms, therefore, we expect the effects of physiotherapy will be more sustainable than the effects of conventional treatment.
Methods: Wedesigned a randomised controlled trial (RCT) of children aged 4–17 years with functional constipation diagnosed by a general practitioner or pediatrician. Children in the intervention group received physiotherapy plus conventional treatment, and those in the control group received conventional treatment only. The primary outcome was treatment success over 8 months, defined as the absence of FC (Rome III criteria) without laxative use. Secondary outcomes included the absence of FC irrespective of continuation of laxative use, quality of life, global perceived treatment effect and costs. The sample size was calculated with expected treatment success rates after 6–12 months of 50% and 75% in the conventional and intervention groups, respectively. Given an expected loss to follow-up of 10%, we estimated a total sample size of 128 children (alpha 0.05, power 0.80).
Clinical impact: The results of this trial will provide valuable information for general practitioners and others involved in the treatment of children with functional constipation, and for stakeholders involved in clinical decision making.
Aard van het onderzoek
Design van het onderzoek
Marjolein Berger (projectleider)
Janny Dekker (projectgroeplid)
Alice van Ulsen-Rust (projecgroeplid)
Merit Tabbers (projectgroep adviseur)
Boudewijn Kollen (projectgroep adviseur)
Karin Vermeulen (projectgroep adviseur)
Yvonne Lisman- van Leeuwen (projectgroep adviseur)