Skip to content

Hirschsprung's Disease: Surgical Techniques and Quality of Life

Quality of Life in Patients With Hirschsprung's Disease in Relation to Surgical Technique: a Study of a Danish Population

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04977752
Enrollment
207
Registered
2021-07-27
Start date
2020-07-01
Completion date
2022-01-14
Last updated
2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Brief summary

This is an observational study examining the long-term quality of life in patients with Hirschsprung's Disease in relation to the choice of surgical technique.

Detailed description

Hirschsprung's Disease (HD) is a developmental defect causing functional obstruction of bowel. It is a condition that almost always requires surgical intervention. This study aims to examine the relation between quality of life and surgical technique in patients with Hirschsprung's disease in hopes of providing insight into advantages and disadvantages of different surgical techniques employed at OUH, department for general surgery in the time between 1985 and 2012. This will be done based on answers given on a set of validated questionnaires that has been sent to all patients diagnosed with HD in the years 1985 to 2012 at OUH, department for general surgery.

Interventions

None listed

Sponsors

University of Southern Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients diagnosed with HD at the Surgical Department at Odense University Hospital from 1985 to 2012 will be invited to enroll in the study.

Exclusion criteria

* lack of informed consent, pregnancy, wrong diagnosis and inability to understand or answer the questionnaires.

Design outcomes

Primary

MeasureTime frameDescription
Hirschsprung Quality of life Questionnaire sub scales and total scoreDay 1Disease specific questionnaire including sub scales for laxative and constipating diet, presence of diarrhoea and constipation, faecal and urinary incontinence, social and emotional functioning, body image, physical symptoms and sexual functioning. Each item is phrased as a multiple-choice question with four response options; never, once in a while, often and very often. Responses are linearly transformed on a 0-100 scale with a higher score indicating better QOL.
General Quality of LifeDay 1Based on a generic SF-36 questionnaire subscaled into perception of health, physical functioning, physical role functioning, emotional functioning and emotional role functioning. Each question is phrased as a multiple-choice question with varying options depending on the type of question.
Type of Surgical InterventionDay 1At our centre three different types of surgical approaches have been employed: Soave operation, Low anterior resection (Rehbeins operation) and trans-anal pullthrough. These outcomes will be correlated to outcomes of quality of life in other to compare the resulting quality of life between the different surgical approaches.

Secondary

MeasureTime frameDescription
Rate of ComplicationsDay 1Data will be retrieved through electronic medical journals. Data such as short term and long term major postoperative complications will be gathered in order to compare prevalence of surgical complications to type of surgical approach.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026