Hirschsprung DiseaseNCT04957667
Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population
An observational study of Hirschsprung Disease, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This study aims to investigate long term outcomes of surgical intervention for Hirschsprung's disease and to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hirschsprung Disease
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients operated for Hirschsprung's disease from 1985-2014 are gathered in a cohort, intended for several studies on Hirschsprung's disease. All patients > 15 years from this cohort will be invited to participate in this study.
Who may be able to join
- Patients operated with any type of surgery for Hirschsprung's disease between 1985-2014
- Age > 15 years
Who cannot join
- Unable to understand given instructions in relation to the defecography (ex. retarded)
- Pregnancy
- Missing consent
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate long term outcomes of surgical intervention for Hirschsprung's disease and to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire.
Read the detailed description
Hirschsprung's disease (HD) is a congenital deficiency with incomplete development of nerves in the gastrointestinal tract leading to absence of peristalsis in the affected segment of bowel. Most patients require surgical intervention with removal of the affected segment of bowel. Physical symptoms affecting quality of life are not uncommon in patients born with HD in spite of surgical intervention. This renders a need for a tool for evaluating the functional outcome in these patients.
Scintigraphic defecography examines the defecation in terms of the ability to empty the bowel and examines the relocation of faeces within the bowel in relation to defecation.
This study aims to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire (Hirschsprung and Anorectal Malformations Quality of Life Questionnaire).
- Conditions
- Hirschsprung Disease
- Keywords
- Hirschsprung disease, Scintigraphic defecography
- Medical subject headings
- Hirschsprung Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Evacuation fraction (%) of radioactive material between first, second and third round of scintigraphic imaging
The fraction of evacuated radioactive material by defecation between rounds of scintigraphic imaging
Measured: Day 1
Presence of retrograde movement of radioactive material (yes/no)
Presence of retrograde movement of radioactive material within the bowel on scintigraphic images between rounds of scintigraphic imaging
Measured: Day 1
Hirschsprung and Anorectal Malformations 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.
Measured: Day 1
Type of surgical intervention performed in each individual (for example pull-through surgery)
Type of surgical intervention performed to treat Hirschsprung's disease
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Feb 2020
- Primary completion1 Jul 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957667
- Sponsor's protocol ID
- HD-NQ-2018
- Status last verified
- Nov 2022
- First submitted
- 31 May 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population
- ClinicalTrials.gov ID
- NCT04957667
- Acronym / sponsor ID
- HD-NQ-2018
- Conditions
- Hirschsprung Disease
- Keywords
- Hirschsprung disease, Scintigraphic defecography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate long term outcomes of surgical intervention for Hirschsprung's disease and to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire.
Detailed description
Hirschsprung's disease (HD) is a congenital deficiency with incomplete development of nerves in the gastrointestinal tract leading to absence of peristalsis in the affected segment of bowel. Most patients require surgical intervention with removal of the affected segment of bowel. Physical symptoms affecting quality of life are not uncommon in patients born with HD in spite of surgical intervention. This renders a need for a tool for evaluating the functional outcome in these patients.
Scintigraphic defecography examines the defecation in terms of the ability to empty the bowel and examines the relocation of faeces within the bowel in relation to defecation.
This study aims to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire (Hirschsprung and Anorectal Malformations Quality of Life Questionnaire).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients operated for Hirschsprung's disease from 1985-2014 are gathered in a cohort, intended for several studies on Hirschsprung's disease. All patients > 15 years from this cohort will be invited to participate in this study.
Key inclusion criteria (2 listed)
- Patients operated with any type of surgery for Hirschsprung's disease between 1985-2014
- Age > 15 years
Key exclusion criteria (3 listed)
- Unable to understand given instructions in relation to the defecography (ex. retarded)
- Pregnancy
- Missing consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evacuation fraction (%) of radioactive material between first, second and third round of scintigraphic imaging
Time frame: Day 1
The fraction of evacuated radioactive material by defecation between rounds of scintigraphic imaging
Presence of retrograde movement of radioactive material (yes/no)
Time frame: Day 1
Presence of retrograde movement of radioactive material within the bowel on scintigraphic images between rounds of scintigraphic imaging
Hirschsprung and Anorectal Malformations Quality of life Questionnaire sub scales and total score
Time frame: Day 1
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.
Type of surgical intervention performed in each individual (for example pull-through surgery)
Time frame: Day 1
Type of surgical intervention performed to treat Hirschsprung's disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hirschsprung Disease, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evacuation fraction (%) of radioactive material between first, second and third round of scintigraphic imaging (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.