Outpatient Treatment of Constipation in Children
This study is currently recruiting participants.
Verified November 2012 by Vejle Hospital
Sponsor:
Line Modin
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Line Modin, Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01582659
First received: March 27, 2012
Last updated: November 19, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Constipation |
Other: Telephone counseling Other: Web access |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Outpatient Treatment of Constipation in Children - a Randomized Interventions Study |
Resource links provided by NLM:
Further study details as provided by Vejle Hospital:
Primary Outcome Measures:
- Treatment recovery [ Time Frame: 1 year ] [ Designated as safety issue: No ]Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.
Secondary Outcome Measures:
- Usage of laxative. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Amount of laxative used during the study periode.
- Telephone contacts [ Time Frame: 1 year ] [ Designated as safety issue: No ]Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted.
| Estimated Enrollment: | 225 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: No ekstra counseling
Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made.
|
|
|
Active Comparator: 2 counseling sessions
Standardized information about childhood constipation is given and the child receives PEG 3350. 2 additional follow up appointments by telephone are made.
|
Other: Telephone counseling
2 planned telephone counseling sessions are conducted.
Other Name: Telephone
|
|
Active Comparator: 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.
|
Other: Web access
Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.
Other Name: Web
|
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582659
Locations
| Denmark | |
| Line Modin | Recruiting |
| Kolding, Denmark, 6000 | |
| Contact: Line Modin, MD 61-386349 line.modin@slb.regionsyddanmark.dk | |
| Pediatric department, Kolding Hospital | Recruiting |
| Kolding, Denmark, 6000 | |
| Contact: Line Modin, MD line.modin@slb.regionsyddanmark.dk | |
Sponsors and Collaborators
Line Modin
University of Southern Denmark
Investigators
| Study Director: | Marianne Jakobsen, MD, PhD | Kolding |
| Study Chair: | Poul Erik Kofoed, MD. PHD | Kolding |
| Principal Investigator: | Line Modin, MD | Kolding |
More Information
No publications provided
| Responsible Party: | Line Modin, Medical doctor, Vejle Hospital |
| ClinicalTrials.gov Identifier: | NCT01582659 History of Changes |
| Other Study ID Numbers: | OutCon |
| Study First Received: | March 27, 2012 |
| Last Updated: | November 19, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Vejle Hospital:
|
constipation children outpatient |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013