This study had two objectives:1. which factors determine outcome of treatment of children with functional childhood constipation referred to the outpatient clinic of multidisciplinary treatment clinics in the Netherlands;2. which factors can be…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A sustained response to treatment 6 months after start of treatment, defined
as: the patient having a stool frequency of at least three times weekly,
without fecal incontinence. Sustained response is defined as successfully
treated as defined above in the absence of relapse of symptoms, and
irrespective of laxative treatment. At 6 months patients are considered either
responder or non-responder to therapy.
Secondary outcome
not applicable
Background summary
Functional constipation in childhood is a chronic condition, with frequent
relapses over a long period of time, and lasting until adulthood. It poses a
great burden on families, social interactions and on quality of life. Factors
influencing treatment outcome are largely unknown and published data are
inconclusive. By identifying factors that influences treatment outcome,
subgroups of patients with a poor outcome can be defined. Treatment of these
patients can then be adjusted in order to improve outcome of treatment..
Primary study endpoint: number of patients treated successfully 6 months after
start of treatment, and the improvement in Quality of Life at treatment success
compared to a Dutch reference group of healthy children.
Study objective
This study had two objectives:
1. which factors determine outcome of treatment of children with functional
childhood constipation referred to
the outpatient clinic of multidisciplinary treatment clinics in the
Netherlands;
2. which factors can be related to an improvement in quality of life of
children with
functional childhood constipation referred to the outpatient clinic of
multidisciplinary treatment teams in
the Netherlands
Study design
Prospective multicenter observational follow-up study. Total duration of the
study: 24 months.
Recruitment period: 12 months, and follow-up period: 12 months. Total number of
patients: 600.
Patients will be included from 4 multidisciplinary treatment teams in The
Netherlands. Each participating center will include 200 patients.
Study burden and risks
not applicable
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
Functional Childhood Constipation in children under the age of 4 (Rome III criteria (31):
Must include 1 month of at least 2 of the following in infants up to 4 years of age: 1. Two or fewer defecations per week, 2. at least 1 episode per week of incontinence after the acquisition of toileting skills, 3. History of excessive stool retention, 4. History of painful or hard bowel movements, 5. Presence of a large fecal mass in the rectum, 6. History of large-diameter stools that may obstruct the toilet*.
Functional Childhood constipation in a child with a developmental age of at least 4 years with insufficient criteria of IBS (Rome III criteria):
Must include 2 or more of the following: 1. Two or fewer defecations per week, 2. at least one episode of fecal incontinence per week, 3. Stool retentive posturing, 4. Painful or hard bowel movements, 5. Large diameter stools that could obstruct the toilet, 6. Presence of a large fecal mass in the abdomen or rectum.
Age 0 - 16 years. Written informed consent by both parents and/or by patient in the age of 12-18 years.
Exclusion criteria
Children with organic cause of constipation: Hirschsprung*s disease, anorectal malformations, neuronal intestinal dysplasia, Spinal cord abnormalities, spinal cord trauma, neurofibromatosis, tethered cord, Hypothyroidism, diabetes mellitus, hypercalcemia, hypokalemia, vitamine D intoxication, Drug use: opoids, anticholinergic agents, antidepressants, Anorexia nervosa, sexual abuse, cystic fibrosis, dietary protein allergy.
Age above 18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46945.101.13 |