- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04106947
Transition of Care for Patients With Hirschsprung Disease and Anorectal Malformations (NOHARM)
February 22, 2021 updated by: Anders Telle Hoel, Oslo University Hospital
Transition from paediatric to adult health care is crucial for preventing deterioration of chronic diseases.
At present, transitional care (TC) is not established for patients with the Hirschsprung disease (H) and Anorectal Malformations (ARM).
To set up a program for TC and to treat persisting symptoms in adults, data on outcome in adult patients are needed.
At present such data are very limited.
Therefore, we want to investigate clinical and PROM in H and ARM adolescents and adults.
A cross sectional study in all H and ARM patients operated in Norway from 1970-2000 and in all adolescents operated at Oslo University Hospital from 2002-2006 will examine somatic, psychosocial and mental health, and quality of life (QoL).
In children operated for H and ARM a large body of evidence shows that bowel problems, reduced QoL and impaired psychosocial and mental health are common.
There are papers on sexual and urological impairment in these patients, but large studies on the topic is missing.
It is a general assumption among paediatric surgeons that both somatic and mental health problems related to H and ARM improve during adolescence and adult life.
Therefore, no standardized guidelines for TC in these patients have been established.
Interestingly, very few studies have actually examined H and ARM patients beyond adolescence.
Reports from patient organizations showing significant long-term sequels and inadequate understanding of the unique problems of H and ARM patients among health professionals treating adults.
Hypothesis:H and ARM adults and adolescents have bowel, urinary and sexual difficulties and reduced QoL, psychosocial and mental health.
H and ARM adults receive insufficient treatment of their chronic congenital disease.
H and ARM patients with syndromes have particularly bad functional outcome.
Anal dilatations and repeated rectal enemas have a negative impact on adolescent psychosocial and mental health.
Main aim: Acquire knowledge about long-term bowel, urinary and sexual function, QoL and psychosocial and mental health in adult and adolescent H and ARM patients.
Results: from this large study of H and ARM patients will have significant influence on treatment and follow-up, both nationally and internationally.
Since very few countries except the Nordic countries have the possibility to follow patients with congenital malformations into adulthood, it is important that studies like this are done.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway
- Oslo University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Alle patients with Hirschsprung and anorectal malformations living in Norway
Description
Inclusion Criteria:
Alle patients with Hirschsprung and anorectal malformation
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with Hirschsprung and anorectal malformation
Patients with Hirschsprung and anorectal malformation living in Norway
|
Questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
questionnaire: BFS
Time Frame: 2 years
|
Acquire knowledge about long-term bowel function in adult and adolescent H and ARM patients
|
2 years
|
questionnaire: DAN-PSS
Time Frame: 2 years
|
Acquire knowledge about urinary function in adult and adolescent H and ARM patients
|
2 years
|
urinary flow-residual
Time Frame: 2 years
|
Acquire knowledge about urinary function in adult and adolescent H and ARM patients
|
2 years
|
questionnaire: PIQS12 and IIEF-5
Time Frame: 2 years
|
Acquire knowledge about sexual function in adult and adolescent H and ARM patients
|
2 years
|
questionnaire
Time Frame: 2 years
|
Acquire knowledge about quality of life in adult and adolescent H and ARM patients
|
2 years
|
questionnaires
Time Frame: 2 years
|
Acquire knowledge about mental Health in adult and adolescent H and ARM patients
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Focus Group interviews With adult Hirschsprung's disease (HD) and anorectal malformations (ARM) patients
Time Frame: 2 years
|
Acquire knowledge about how adult H and ARM patients have experienced and would design transition from paediatric to adult health care
|
2 years
|
Questionnaires (impact of event scale) to adolescent and parent. Focus Group interviews will be applied for parents.
Time Frame: 2 years
|
Acquire knowledge about the influence of anal dilatations and regular rectal enemas on psychosocial and mental health in adolescents
|
2 years
|
Focus Group interviews will be applied for parents.
Time Frame: 2 years
|
Acquire knowledge about the influence of anal dilatations and regular rectal enemas on psychosocial and mental health in adolescents
|
2 years
|
Questionnaires to next of kin to syndromic patients
Time Frame: 2 years
|
Acquire knowledge about bowel function in adult syndromic H and ARM patients
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kristin Bjørnland, Prof, Oslo University Hospital and University of Oslo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 12, 2019
Primary Completion (ANTICIPATED)
August 1, 2021
Study Completion (ANTICIPATED)
August 1, 2022
Study Registration Dates
First Submitted
September 20, 2019
First Submitted That Met QC Criteria
September 25, 2019
First Posted (ACTUAL)
September 27, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 23, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18/19101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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