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van CCT (UK)

van CCT (UK)

Treatment of childhood constipation in general practice.

- candidate number14453
- NTR NumberNTR3878
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mrt-2013
- Secondary IDsNL43786.042.13 CCMO
- Public TitleTreatment of childhood constipation in general practice.
- Scientific TitlePaediatric physiotherapy versus usual care for the treatment of childhood constipation in general practice.
- hypothesisPelvic physiotherapy is more effective than usual care (laxatives) for the treatment of functional constipation.
- Healt Condition(s) or Problem(s) studiedConstipation, Children, Physiotherapy, Primary care
- Inclusion criteria1. Age 4-17 years;
2. Functional constipation defined by the NHG Standaard Obstipatie as having at least two of the following symptoms:
A. Defecation ≤ 2 per week;
B. Cessation of defecation;
C. Painful, lumpy or hard defecation;
D. Large diameter stools that may obstruct the toilet;
E. Presence of a large faecal mass in the rectum or abdomen;
F. ≥ 1 episode of faecal incontinence per week.
- Exclusion criteria1. Terminal illness;
2. Mental retardation;
3. Metabolic disease (e.g. hypothyreoidi);
4. Hirchsprung disease/ spine anomalies/ anorectal pathology (e.g. hemorrhoids, anal fissure, perirectal abscess, pruritis ani, fecal incontinence);
5. Gastrointestinal surgery in medical history;
6. Presence of an indication for referral to secondary care: suspicion for ileus, Hirchsprung disease, anatomic malformation or pelvic floor pathology, severe behavioural problems, developmental problems or a disturbed parent-child relationship concerning defecation;
7. Contraindication for PEG3350 electrolytes (e.g.Toxic megacolon, Inflammatory bowel disease, acute abdominal pain, allergies for one of the substances);
8. Children who already receive laxative treatment prescribed by the GP or children for who it's less than 3 months ago that they stopped taking laxatives.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2013
- planned closingdate1-sep-2014
- Target number of participants50
- InterventionsComparison of a treatment with laxatives with a peadiatric treatment for functional childhood constipation in primary care. The peadiatric treatment focusses on toilet training; how they should relax and breath. Laxatives will be prescribed as usual. Both interventions have a maximum of 24 weeks. Treatment will be stopped if there are no more complaints or when the treating doctor thinks further treatment is without value.
- Primary outcomeTo asses the feasibility of conducting a RCT comparing the effect of paediatric physiotherapy with the effect of laxative treatment on symptoms of functional constipation in children in primary care.
- Secondary outcome1. Treatment succes;
2. Quality of life;
3. Medication use;
4. Costs.
- TimepointsFollow-up at 12 and 24 weeks. Measurements will be taken through questionnaires and a stool diary.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryConstipation is the most common gastro-intestinal disorder in childhood. Laxative treatment is currently recommended as the first choice therapy for children with functional constipation in primary care (usual care). However, while the effect of paediatric physiotherapy is not yet evidence-base, this therapy might also be helpful for children with functional constipation in primary care. Furthermore it is unknown if there is a difference in medication use, quality of life and costs when these two treatments are compared with each other.
- Main changes (audit trail)
- RECORD1-mrt-2013 - 13-mrt-2013

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