Anorectal MalformationsNOHARMNCT04106947
Transition of Care for Patients With Hirschsprung Disease and Anorectal Malformations
An observational study of Anorectal Malformations and Transition, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Anorectal Malformations, Transition, Quality of Life
- What is being tested?
- Questionnaires
- How many people
- 1,000 participants
- Where
- 1 siteNorway
- Study dates
- 12 Aug 2019to Aug 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Alle patients with Hirschsprung and anorectal malformations living in Norway
Who may be able to join
- Alle patients with Hirschsprung and anorectal malformation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Questionnaires
- Medical subject headings
- Anorectal Malformations, Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients with Hirschsprung and anorectal malformation | Patients with Hirschsprung and anorectal malformation living in Norway Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire: BFS
Acquire knowledge about long-term bowel function in adult and adolescent H and ARM patients
Measured: 2 years
questionnaire: DAN-PSS
Acquire knowledge about urinary function in adult and adolescent H and ARM patients
Measured: 2 years
urinary flow-residual
Acquire knowledge about urinary function in adult and adolescent H and ARM patients
Measured: 2 years
questionnaire: PIQS12 and IIEF-5
Acquire knowledge about sexual function in adult and adolescent H and ARM patients
Measured: 2 years
questionnaire
Acquire knowledge about quality of life in adult and adolescent H and ARM patients
Measured: 2 years
questionnaires
Acquire knowledge about mental Health in adult and adolescent H and ARM patients
Measured: 2 years
Secondary outcomes (4)
Focus Group interviews With adult Hirschsprung's disease (HD) and anorectal malformations (ARM) patients
Acquire knowledge about how adult H and ARM patients have experienced and would design transition from paediatric to adult health care
Measured: 2 years
Questionnaires (impact of event scale) to adolescent and parent. Focus Group interviews will be applied for parents.
Acquire knowledge about the influence of anal dilatations and regular rectal enemas on psychosocial and mental health in adolescents
Measured: 2 years
Focus Group interviews will be applied for parents.
Acquire knowledge about the influence of anal dilatations and regular rectal enemas on psychosocial and mental health in adolescents
Measured: 2 years
Questionnaires to next of kin to syndromic patients
Acquire knowledge about bowel function in adult syndromic H and ARM patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start12 Aug 2019
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal MalformationsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, Skane University Hospital, St. Olavs Hospital
- Responsible party
- Principal investigator, Anders Telle Hoel, Oslo University Hospital
- Investigators
- Kristin Bjørnland, Prof, Study chair, Oslo University Hospital and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106947
- Sponsor's protocol ID
- 18/19101
- Acronym
- NOHARM
- Status last verified
- Feb 2021
- First submitted
- 20 Sep 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition of Care for Patients With Hirschsprung Disease and Anorectal Malformations
- ClinicalTrials.gov ID
- NCT04106947
- Acronym / sponsor ID
- NOHARM / 18/19101
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, Skane University Hospital, St. Olavs Hospital
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Hirschsprung and anorectal malformation | – | Other: QuestionnairesPatients with Hirschsprung and anorectal malformation living in Norway |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Alle patients with Hirschsprung and anorectal malformations living in Norway
Key inclusion criteria (1 listed)
- Alle patients with Hirschsprung and anorectal malformation
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires | Other | Patients with Hirschsprung and anorectal malformation |
Primary outcome
questionnaire: BFS
Time frame: 2 years
Acquire knowledge about long-term bowel function in adult and adolescent H and ARM patients
questionnaire: DAN-PSS
Time frame: 2 years
Acquire knowledge about urinary function in adult and adolescent H and ARM patients
urinary flow-residual
Time frame: 2 years
Acquire knowledge about urinary function in adult and adolescent H and ARM patients
questionnaire: PIQS12 and IIEF-5
Time frame: 2 years
Acquire knowledge about sexual function in adult and adolescent H and ARM patients
questionnaire
Time frame: 2 years
Acquire knowledge about quality of life in adult and adolescent H and ARM patients
questionnaires
Time frame: 2 years
Acquire knowledge about mental Health in adult and adolescent H and ARM patients
4 secondary outcomes
Focus Group interviews With adult Hirschsprung's disease (HD) and anorectal malformations (ARM) patients
Time frame: 2 years
Questionnaires (impact of event scale) to adolescent and parent. Focus Group interviews will be applied for parents.
Time frame: 2 years
Focus Group interviews will be applied for parents.
Time frame: 2 years
Questionnaires to next of kin to syndromic patients
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Bjørnland, Prof study chair
Oslo University Hospital and University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorectal Malformations and Transition, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire: BFS (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.