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Behandeling van Obstipatie bij Kinderen


- candidate number19408
- NTR NumberNTR4797
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-sep-2014
- Secondary IDs80-83700-98-41027 ZonMW
- Public TitleBehandeling van Obstipatie bij Kinderen
- Scientific TitlePediatric pelvic physiotherapy added to conventional treatment of functional constipation in children in primary care
- ACRONYMBOKi
- hypothesisWe expect paediatric pelvic physiotherapy in addition to conventional treatment to be more (cost)- effective than conventional treatment alone, after 8 months follow-up.
- Healt Condition(s) or Problem(s) studiedChildren, Obstipation, Physiotherapy
- Inclusion criteriaChildren aged 4 to 17 years who fulfil the paediatric ROME III criteria* of functional constipation i.e. two or more of the following:
- 2 or fewer bowel movements in the toilet per week
- At least 1 episode of faecal incontinence per week
- History of retentive posturing or excessive volitional stool retention
- History of painful or hard bowel movements
- Presence of a large faecal mass in the rectum
- History of large diameter stools that may obstruct the toilet
- Exclusion criteria- Mental retardation
- Severe/terminal illness
- Psychiatric pathology
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-jan-2017
- Target number of participants180
- InterventionsPaediatric pelvic physiotherapy will be given by a certified paediatric physiotherapist with additional education in pelvic physiotherapy, according to the standards of the Dutch Pelvic Physiotherapists¡¯ Organization (NVFB). Treatment will start within one week after randomisation. The therapy will consist of assessment of motor development, extensive physiotherapy training, breath control, pelvic floor training, core stability training and abdominal massage. It includes isometric training of the abdominal muscles, defecation stimulating exercises on the toilet, and relaxation and diaphragmatic breathing exercises.
The paediatric physiotherapist will decide on treatment frequency and duration (usually 3-6 sessions). We will not use a standard protocol for the physiotherapeutic intervention but chose a more flexible, pragmatic approach in which the participating pediatric physiotherapists tailor their treatment to the need of each child, as would be the case in normal practice.
To gain insight in the treatment techniques and treatment duration in our study population pediatric physiotherapists register their treatment and the number of visits for each patient on a structured form during 12 months follow up.
- Primary outcomeTreatment success at 12 months follow-up.
Treatment success is defined as the absence of constipation according the QPGS ROME III questionnaire.
- Secondary outcomeSecondary outcome measures are treatment success at 4 months, quality of life, and costs.
- TimepointsFollow up visits will be at 4 and 12 months.
- Trial web sitewww.boki-onderzoek.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMSc. J.J.G.T. Summeren, van
- CONTACT for SCIENTIFIC QUERIESprof. dr. M.Y. Berger
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of General Practice
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryRationale: Education, dietary advice, toilet training and laxative treatment is currently recommended as the first choice therapy for children with functional constipation in primary care (conventional treatment). Paediatric pelvic physiotherapists claim to obtain good results with their treatment and they already treat many children with functional constipation. However because a lack of randomised controlled trials, paediatric pelvic physiotherapy is not yet evidence-based.

Objective: The primary objective is to study the effect of paediatric pelvic physiotherapy in addition to conventional therapy on the number of patients with treatment success in children aged 4-17 years in primary care with functional constipation in comparison to conventional treatment alone.

Study design: Randomised controlled trial with a follow-up of 8 months.

Study population: Children aged 4-17 years with functional constipation in primary care.

Intervention: The therapy will consist of education about defecation, toilet training, breathing exercises, training of the pelvic floor muscles, and training of the abdominal muscles. This will be added to the conventional treatment of functional constipation.

Main study parameters/endpoints: Primary outcome measure is treatment success at 8 months follow-up. Treatment success is defined as the absence of constipation according the ROME III criteria for functional constipation; without using laxative treatment in the past 4 weeks. Secondary outcome measures are treatment success at 4 months, absence of constipation irrespective of laxative use at 4 and 8 months, quality of life and costs.
- Main changes (audit trail)7-okt-2016:

Inclusion criteria NEW:
- Children aged 4 to 17 years
- Diagnosis of functional constipation by GP or Paediatrician
- Informed consent of both parents and the child (if aged ¡İ 12 years)

Exclusion criteria NEW:
- Physiotherapy or urotherapy for constipation in the past 3 years
- Psychopathology disabling protocol adherence
- Severe/terminal ilness

Interventions NEW:
Paediatric pelvic physiotherapy will be given by a certified paediatric physiotherapist with additional education in pelvic physiotherapy, according to the standards of the Dutch Pelvic Physiotherapists Organization (NVFB). Treatment will start within one week after randomisation. The therapy will consist of assessment of motor development, extensive physiotherapy training, breath control, pelvic floor training, core stability training and abdominal massage. It includes isometric training of the abdominal muscles, defecation stimulating exercises on the toilet, and relaxation and diaphragmatic breathing exercises.
The paediatric physiotherapist will decide on treatment frequency and duration (usually 3-6 sessions). We will not use a standard protocol for the physiotherapeutic intervention but chose a more flexible, pragmatic approach in which the participating pediatric physiotherapists tailor their treatment to the need of each child, as would be the case in normal practice. To gain insight in the treatment techniques and treatment duration in our study population pediatric physiotherapists register their treatment and the number of visits for each patient on a structured form.

Primary outcome NEW:
Treatment success at 8 months follow-up. Treatment success is defined as the absence of constipation according the QPGS ROME III questionnaire without the use of laxatives.

Secondary outcome NEW:
Secondary outcome measures are treatment success at 4 months, the absence of constipation according to the ROME III criteria in the past 4 weeks irrespective of the use of laxatives at 4 and 8 months, quality of life, costs.

Time points NEW:
Follow up visits will be at 4 and 8 months
- RECORD8-sep-2014 - 22-okt-2017


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