Pelvic physiotherapy is more effective than usual care (laxatives) for the treatment of functional constipation.
ID
Bron
Aandoening
childhood constipation, paediatric physiotherapy, primary care
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To 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.
Achtergrond van het onderzoek
Constipation 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.
Doel van het onderzoek
Pelvic physiotherapy is more effective than usual care (laxatives) for the treatment of functional constipation.
Onderzoeksopzet
Follow-up at 12 and 24 weeks. Measurements will be taken through questionnaires and a stool diary.
Onderzoeksproduct en/of interventie
Comparison 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.
Publiek
Postbus 196
I. Middendorp
Groningen 9700 AD
The Netherlands
+31 (0)50 3632989
ingemiddendorp@hotmail.com
Wetenschappelijk
Postbus 196
I. Middendorp
Groningen 9700 AD
The Netherlands
+31 (0)50 3632989
ingemiddendorp@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL3715 |
NTR-old | NTR3878 |
CCMO | NL43786.042.13 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |