Hirschsprung DiseaseNCT04622410
Registry for Hirschsprung Disease of the BELAPS
An observational study of Hirschsprung Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Registry for Hirschsprung disease of the BELAPS (Belgian Association of Pediatric Surgery) Protocol Short Title/Acronym / Sponsor name BELAPS Principal Investigator Prof. Dr. Marc Miserez Medical condition or disease under investigation Hirschsprung's disease Purpose of clinical study To register pre-, intra- and… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hirschsprung Disease
- How many people
- 432 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2012to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: * All Hirschsprung disease patients consecutively * Male and female * < 18 years * Operated by a participating surgeon * Elective and emergency surgery * Informed consent form signed by the parents of the child
Who may be able to join
- Hirschsprung Disease, surgery
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colette Barle contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Colette Barlé, ++32 16 341699, colette.barle@uzleuven.be
Marc Miserez, Prof.Dr.
About this study
Official title: Registry for Hirschsprung Disease of the BELAPS (Belgian Association of Pediatric Surgery)
Registry for Hirschsprung disease of the BELAPS (Belgian Association of Pediatric Surgery) Protocol Short Title/Acronym
/ Sponsor name BELAPS Principal Investigator Prof. Dr. Marc Miserez Medical condition or disease under investigation Hirschsprung's disease Purpose of clinical study To register pre-, intra- and postoperative data in order to improve surgical care to paediatric patients with Hirschsprung's disease in Belgium. Primary objective The primary objective is to evaluate defecation habits at 3.5-5.5 years after surgery. Secondary objective (s) Evaluating the long-term results and evaluate risk factors for constipation / incontinence. Study Design Prospective registry Endpoints Krickenbeck score, urinary, sexual and QoL evaluation
- Conditions
- Hirschsprung Disease
- Medical subject headings
- Hirschsprung Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To register pre-, intra- and postoperative data in order to improve surgical care to pediatric patients with Hirschsprung's disease in Belgium.
Measured: at least 10 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 May 2012
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Other
- Enrolment
- 432 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622410
- Sponsor's protocol ID
- S51836
- Status last verified
- Jun 2024
- First submitted
- 5 Nov 2020
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Hirschsprung Disease of the BELAPS (Belgian Association of Pediatric Surgery)
- ClinicalTrials.gov ID
- NCT04622410
- Acronym / sponsor ID
- S51836
- Conditions
- Hirschsprung Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Nov 2020 (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.
Registry for Hirschsprung disease of the BELAPS (Belgian Association of Pediatric Surgery) Protocol Short Title/Acronym
/ Sponsor name BELAPS Principal Investigator Prof. Dr. Marc Miserez Medical condition or disease under investigation Hirschsprung's disease Purpose of clinical study To register pre-, intra- and postoperative data in order to improve surgical care to paediatric patients with Hirschsprung's disease in Belgium. Primary objective The primary objective is to evaluate defecation habits at 3.5-5.5 years after surgery. Secondary objective (s) Evaluating the long-term results and evaluate risk factors for constipation / incontinence. Study Design Prospective registry Endpoints Krickenbeck score, urinary, sexual and QoL evaluation
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- * All Hirschsprung disease patients consecutively * Male and female * < 18 years * Operated by a participating surgeon * Elective and emergency surgery * Informed consent form signed by the parents of the child
Key inclusion criteria (1 listed)
- Hirschsprung Disease, surgery
Key exclusion criteria (1 listed)
- -
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
To register pre-, intra- and postoperative data in order to improve surgical care to pediatric patients with Hirschsprung's disease in Belgium.
Time frame: at least 10 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
Colette Barle contact
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 Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Jul 2024. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colette Barle (colette.barle@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To register pre-, intra- and postoperative data in order to improve surgical care to pediatric patients with Hirschsprung's disease in Belgium. (time frame: at least 10 years postoperatively). 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 1 Jul 2024.