Translation and Validation of a Disease-specific Questionnaire for Hirschsprung's Disease in Danish Patients

NCT ID: NCT04730128

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-05-15

Brief Summary

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The Hirschsprung and anorectal malformation quality of life (HAQL) questionnaire is a disease-specific quality of life questionnaire with 5 different elements (3 questionnaires for patients (categories: age 8-11, 12-16, and \>17 years) and two questionnaires for parents of patients (categories: patients aged 8-11 and 12-16 years).

In the first part of this study, the questionnaires will be translated via forward-backward-translation, culturally adapted and evaluated for content validity.

In the second part of the study, the questionnaires will be validated in a cohort of all eligible Hirschsprung patients from Odense University Hospital from 1985-2014.

Detailed Description

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Conditions

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Hirschsprung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Hirschsprung's Disease between the years 1985-2014
* Age \> 7 years
* Good Danish comprehension
* Signed informed consent

Exclusion Criteria

* Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kristina Gosvig

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Odense University Hospital

Odense, Region Syddanmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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011-2018-NQ

Identifier Type: -

Identifier Source: org_study_id

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