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Transition of Care for Patients With Hirschsprung Disease and Anorectal Malformations (NOHARM)

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ClinicalTrials.gov Identifier: NCT04106947
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
University Hospital, Akershus
Skane University Hospital
St. Olavs Hospital
Information provided by (Responsible Party):
Anders Telle Hoel, Oslo University Hospital

Brief 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). 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.

Condition or disease Intervention/treatment
Anorectal Malformations Transition Quality of Life Hirschsprung Disease Other: Questionnaires

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Transition of Care for Patients With Hirschsprung Disease and Anorectal Malformations
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022


Group/Cohort Intervention/treatment
Patients with Hirschsprung and anorectal malformation
Patients with Hirschsprung and anorectal malformation living in Norway
Other: Questionnaires
Questionnaires




Primary Outcome Measures :
  1. questionnaire: BFS [ Time Frame: 2 years ]
    Acquire knowledge about long-term bowel function in adult and adolescent H and ARM patients

  2. questionnaire: DAN-PSS [ Time Frame: 2 years ]
    Acquire knowledge about urinary function in adult and adolescent H and ARM patients

  3. urinary flow-residual [ Time Frame: 2 years ]
    Acquire knowledge about urinary function in adult and adolescent H and ARM patients

  4. questionnaire: PIQS12 and IIEF-5 [ Time Frame: 2 years ]
    Acquire knowledge about sexual function in adult and adolescent H and ARM patients

  5. questionnaire [ Time Frame: 2 years ]
    Acquire knowledge about quality of life in adult and adolescent H and ARM patients

  6. questionnaires [ Time Frame: 2 years ]
    Acquire knowledge about mental Health in adult and adolescent H and ARM patients


Secondary Outcome Measures :
  1. 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. 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

  3. 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

  4. Questionnaires to next of kin to syndromic patients [ Time Frame: 2 years ]
    Acquire knowledge about bowel function in adult syndromic H and ARM patients



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Alle patients with Hirschsprung and anorectal malformations living in Norway
Criteria

Inclusion Criteria:

Alle patients with Hirschsprung and anorectal malformation

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106947


Contacts
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Contact: Anders Telle Hoel, MD 004798483047 andho@ous-hf.no
Contact: Kristin Bjørnland, Prof kbjornla@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Anders Telle Hoel, MD       andho@ous-hf.no   
Contact: Kristin Bjørnland, Prof       kbjornla@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Skane University Hospital
St. Olavs Hospital
Investigators
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Study Chair: Kristin Bjørnland, Prof Oslo University Hospital and University of Oslo

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Responsible Party: Anders Telle Hoel, Clinical Fellow, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04106947    
Other Study ID Numbers: 18/19101
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hirschsprung Disease
Anorectal Malformations
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases