Outpatient Treatment of Constipation in Children

Line Modin

Status: Completed

Conditions: Constipation

Treatments: Other: Web access; Other: Telephone counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01582659

OutCon

Details and patient eligibility

About

Constipation is a condition often seen in children. Constipation is often associated with impaired quality of life of the child and of great concern among parents. Despite the fact that both diagnosis and treatment is a simple task, it is often seen that the treatment fails, and many children are referred to a pediatric ward for specialized treatment.

There is currently little research on the subject and treatment is therefore based on expert knowledge rather than scientific research.

The study objective is to identify the most effective and least stressful treatment of children with constipation for both families and the health care system.

The following will be tested:

Does treatment of constipation in children require specialized knowledge and extensive resources or can the treatment be simplified?

The results from this study are expected to form the basis for a evidence based treatment of children with constipation.

Enrollment: 239 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children between 2 and 16 years and referral to our out patient clinic with either constipation or fecal incontinence.
• Patients must fulfill the Rome III criteria of constipation, which mean they must have at least 2 of the following characteristics: fewer than 3 bowel movements weekly, more than 1 episode of fecal incontinence weekly, large stools in the rectum by digital rectal examination or palpable on abdominal examination, occasional passing of large stools, display of retentive posturing and withholding behavior, and painful defecation.

Exclusion criteria

• Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
• Children receiving drugs known to affect bowel function during a 2 month period before initiation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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239 participants in 3 patient groups

No ekstra counseling

No Intervention group

Description:

Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made.

2 counseling sessions

Active Comparator group

Description:

Standardized information about childhood constipation is given and the child receives PEG 3350. 2 additional follow up appointments by telephone are made.

Treatment:

Other: Telephone counseling

Web access

Active Comparator group

Description:

Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made but the family are given access to a website with information about childhood constipation.

Treatment:

Other: Web access