Outpatient Treatment of Constipation in Children

Not Applicable

Completed

• Conditions: Constipation
• Interventions: Other: Telephone counseling; Other: Web access

• Registration Number: NCT01582659
• Lead Sponsor: Line Modin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Study Start: 2012-06
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 counseling sessions	Telephone counseling	Standardized information about childhood constipation is given and the child receives PEG 3350. 2 additional follow up appointments by telephone are made.
Web access	Web access	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.

Primary Outcome Measures

Name	Time	Method
Treatment recovery	1 year	Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.

Secondary Outcome Measures

Name	Time	Method
Usage of laxative.	1 year	Amount of laxative used during the study periode.
Telephone contacts	1 year	Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted.

Trial Locations

Locations (2)

Pediatric department, Kolding Hospital; 🇩🇰 Kolding, Denmark

Line Modin; 🇩🇰 Kolding, Denmark