A multicenter randomized controlled trial of the effectiveness of pelvic physical therapy for children 5-17 years with functional constipation as SURPLUS to paediatric usual care

Completed

• Conditions: blocked; constipation; 10017977

• Registration Number: NL-OMON39172
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 367

Inclusion Criteria

* There is functional constipation according to the Rome III criteria.
* The children are being treated for this complaint by a pediatrician or (children)- gastroenterologist
* The children are referred by a pediatrician or (child)- gastroenterologist
* The child (at least 5 years and up to 17 years) at baseline measurement.
* The parents sign an informed consent.
** Children 12 years and older sign an informed consent

Exclusion Criteria

* Severe motor retardation, making it impossible to independently go to the toilet and / or the clothes off and / or sit without help.
* Endocrine and metabolic disorders, such as hypothyroidism, diabetes mellitus and diabetes insipidus.
* Neurological and psychiatric disorders such as autism and PDD-NOS. spina bifida, cerebral palsy, anorexia nervosa.
* Psychiatric disorders such as autism and PDD-NOS.
* SDQ at baseline is above 14
* Down syndrome
* M. Hirschsprung

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure in this study: The Rome III criteria for functional<br /><br>obstipatie in conjunction with the use of macrogol 3350 or 4000.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measurements in this study: The results of the measuring<br /><br>instruments which, in different ways, measure quality of life and the perceived<br /><br>impact of treatment </p><br>