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NCT Number: NCT04730128

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

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.

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Key information

Conditions

Hirschsprung Disease Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Megacolon

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Internal Consistency (IC) assessed by Cronbach's Alpha

    Time frame: Day 1

Secondary outcomes

  1. Test-retest reliability assessed by intraclass-correlations coefficient

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

Translation and Validation of the Hirschsprung and Anorectal Malformation Quality of Life (HAQL) Questionnaire in a Danish Hirschsprung Population

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 29, 2021
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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