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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
01

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.

02

Conditions studied

  • Hirschsprung Disease
  • Bowel; Perforation, Fetus or Newborn
03

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.

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.
04

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

05

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

06

Study locations

No study locations are listed for this record.

07

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.

08

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 ↗

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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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