Behavioural therapy for treatment of childhood constipation: a randomised controlled trial

Completed

Conditions: Constipation
Digestive System
Functional intestinal disorders

Registration Number: ISRCTN25185569

Lead Sponsor: Academic Medical Center (AMC) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 129

Inclusion Criteria

1. Children aged four to 18 years with functional constipation as defined by the classic Iowa criteria
2. Patients had to meet at least two of four criteria of paediatric constipation:
2.1. Defaecation frequency less than three times per week
2.2. Faecal incontinence frequency two or more times per week
2.3. Passage of large amounts of stool at least once every seven to 30 days (large enough to clog the toilet)
2.4. A palpable abdominal or rectal faecal mass

Exclusion Criteria

1. Children were excluded from the study if they had already been treated at our gastrointestinal outpatient clinic or had received a comprehensive behavioural treatment in the previous 12 months
2. In addition, children using drugs influencing gastrointestinal function other than laxative and children with organic causes for defaecation disorders such as Hirschsprung's disease, spina bifida occulta, hypothyroidism or other metabolic or renal abnormalities were excluded

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Defaecation Frequency (DF) per week, Faecal Incontinence Frequency (FIF) per week, successful treatment and relapse. Success was defined as DF more than or equal to three times/week and FIF less than or equal to one time/two weeks irrespectively of laxative use. <br><br>A relapse was defined as being unsuccessful at follow-up, while being successful at post-treatment. Assessments were done post-treatment and at six-months follow-up during a clinical visit or by telephone.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures were: <br>1. Stool-withholding behaviour<br>2. Mean CBCL T-scores <br>3. The proportion of children with behavioural scores in the clinical range (T-score more than 63)<br><br>Assessments were done post-treatment and at six-months follow-up during a clinical visit or by telephone.