NCT04977752

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

July 21, 2021

Last Update Submit

July 21, 2021

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (3)

  • Hirschsprung Quality of life Questionnaire sub scales and total score

    Disease 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.

    Day 1

  • General Quality of Life

    Based 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.

    Day 1

  • Type of Surgical Intervention

    At 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.

    Day 1

Secondary Outcomes (1)

  • Rate of Complications

    Day 1

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with HD at OUH, department for general surgery between 1985 and 2012.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, Fyn, 5000, Denmark

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

July 21, 2021

First Posted

July 27, 2021

Study Start

July 1, 2020

Primary Completion

January 14, 2022

Study Completion

January 14, 2022

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations

DK(1)