Hirschsprung DiseaseNCT05044741
Risk Factors of Perforated HSCR in Neonates
An observational study of Hirschsprung Disease and Bowel; Perforation, Fetus or Newborn, run by Tongji Hospital.
Trial summary
Hirschsprung's disease (HSCR) is a common digestive malformation with radiographic evidence of distal bowel obstruction and clinical signs of abdominal distension, vomiting, constipation, and failure to pass meconium. Read more about this study
- Who is it for?
- Ages 0 to 30 days
- Conditions the study is for
- Hirschsprung Disease, Bowel; Perforation, Fetus or Newborn
- What is being tested?
- Emergency surgical enterostomy
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2019
- 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 0 to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: -Neonates (≤1 month age) with HSCR who suffered with bowel perforation.
Who may be able to join
- Neonates (≤1 month age)
- Diagnosed with HSCR
- Suffered with bowel perforation
Who cannot join
- Patients complicated with suspected necrotizing enterocolitis (NEC), imperforate anus (IA), intestinal atresia, and meconium plug syndrome
- Neonates who transferred from outside participating hospitals.
About this study
Official title: The Risk Factors for Bowel Perforation in Neonates With Hirschsprung Disease
Hirschsprung's disease (HSCR) is a common digestive malformation with radiographic evidence of distal bowel obstruction and clinical signs of abdominal distension, vomiting, constipation, and failure to pass meconium. Bowel perforation (perforated HSCR) is a very serious complication of HSCR, but if this occurs it is most often in the neonatal period. The current study collected information on all cases diagnosed with perforated HSCR from multi-centers in China over 10 years, the aim was to evaluate the clinical features of perforated HSCR, and investigate possible risk factors for perforated HSCR in neonates.
- Being tested
- Emergency surgical enterostomy
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency surgical enterostomyProcedure or surgery
Emergency surgical enterostomy
| Study group | Role | What they receive |
|---|---|---|
| Perforated group | Not described Receives: Procedure: Emergency surgical enterostomy | |
| Controlled group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bowel perforation in neonatal Hirschsprung disease (perforated HSCR)
Cases with bowel perforation in neonatal Hirschsprung disease/ total neonatal Hirschsprung disease
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jan 2006
- Primary completion31 Dec 2010
- Study completion31 Dec 2019
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 Tongji HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Children's Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044741
- Sponsor's protocol ID
- Perforated HSCR
- Status last verified
- Aug 2021
- First submitted
- 27 Aug 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Until now, we do not have the plan to open individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk Factors for Bowel Perforation in Neonates With Hirschsprung Disease
- ClinicalTrials.gov ID
- NCT05044741
- Acronym / sponsor ID
- Perforated HSCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Wuhan Children's Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Sep 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.
Hirschsprung's disease (HSCR) is a common digestive malformation with radiographic evidence of distal bowel obstruction and clinical signs of abdominal distension, vomiting, constipation, and failure to pass meconium. Bowel perforation (perforated HSCR) is a very serious complication of HSCR, but if this occurs it is most often in the neonatal period. The current study collected information on all cases diagnosed with perforated HSCR from multi-centers in China over 10 years, the aim was to evaluate the clinical features of perforated HSCR, and investigate possible risk factors for perforated HSCR in neonates.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perforated group | – | Procedure: Emergency surgical enterostomy |
| Controlled group | – | – |
Who may qualify
- Ages
- 0 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- -Neonates (≤1 month age) with HSCR who suffered with bowel perforation.
Key inclusion criteria (3 listed)
- Neonates (≤1 month age)
- Diagnosed with HSCR
- Suffered with bowel perforation
Key exclusion criteria (2 listed)
- Patients complicated with suspected necrotizing enterocolitis (NEC), imperforate anus (IA), intestinal atresia, and meconium plug syndrome
- Neonates who transferred from outside participating hospitals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency surgical enterostomyEmergency surgical enterostomy | Procedure or surgery | Perforated group |
Primary outcome
Rate of bowel perforation in neonatal Hirschsprung disease (perforated HSCR)
Time frame: 14 years
Cases with bowel perforation in neonatal Hirschsprung disease/ total neonatal Hirschsprung 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 16 Sep 2021.
- Individual participant dataSharing planned: Undecided. Until now, we do not have the plan to open individual participant data.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hirschsprung Disease and Bowel; Perforation, Fetus or Newborn, run by Tongji Hospital.
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 3 inclusion and 2 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of bowel perforation in neonatal Hirschsprung disease (perforated HSCR) (time frame: 14 years). 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 16 Sep 2021.