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CompletedNCT05044741Updated Sep 16, 2021

Risk Factors of Perforated HSCR in Neonates

An observational study in Hirschsprung Disease and Bowel; Perforation, Fetus or Newborn, sponsored by Tongji Hospital. Completed. Open to participants aged 0 Days to 30 Days. Per ClinicalTrials.gov, last updated 2021-09-16.

Sponsored by Tongji Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
600
Ages
0 Days to 30 Days
Sex
All
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Study 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. 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.

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Conditions studied

  • Hirschsprung Disease
  • Bowel; Perforation, Fetus or Newborn

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03

In context

Hirschsprung Disease

63 studies on the registry are indexed under Hirschsprung Disease; 24 are open to participants now.

This study's enrollment of 600 is above the median of 300 across 31 observational studies indexed under Hirschsprung Disease.

Browse Hirschsprung Disease studies →

Lead sponsor

Tongji Hospital is the lead sponsor of 386 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Days to 30 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

-Neonates (≤1 month age) with HSCR who suffered with bowel perforation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Neonates (≤1 month age)
  • Diagnosed with HSCR
  • Suffered with bowel perforation

Exclusion criteria

Exclusion Criteria:

  • Patients complicated with suspected necrotizing enterocolitis (NEC), imperforate anus (IA), intestinal atresia, and meconium plug syndrome
  • Neonates who transferred from outside participating hospitals.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
600 participants (actual)
Patient registry
No

Groups and cohorts

  • Perforated group

    Procedure: Emergency surgical enterostomy

  • Controlled group

Interventions

  • ProcedureEmergency surgical enterostomy

    Emergency surgical enterostomy

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What researchers measure

Primary outcomes

  1. Rate of bowel perforation in neonatal Hirschsprung disease (perforated HSCR)

    Cases with bowel perforation in neonatal Hirschsprung disease/ total neonatal Hirschsprung disease

    Time frame: 14 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided — Until now, we do not have the plan to open individual participant data.

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2006 to primary completion in Dec 2010, 59 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2021
First posted
Sep 16, 2021
StartActual
Jan 1, 2006
Primary completionActual
Dec 31, 2010
CompletionActual
Dec 31, 2019
Last update
Sep 16, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05044741
Lead sponsor
Tongji Hospital
Collaborators
Wuhan Children's Hospital, The First Affiliated Hospital of Zhengzhou University
Responsible party
Sponsor
First posted
Sep 16, 2021
Start date
Jan 1, 2006
Primary completion
Dec 31, 2010
Completion
Dec 31, 2019
Last update
Sep 16, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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