Risk Factors of Perforated HSCR in Neonates

NCT ID: NCT05044741

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hirschsprung Disease Bowel; Perforation, Fetus or Newborn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Perforated group

Emergency surgical enterostomy

Intervention Type PROCEDURE

Emergency surgical enterostomy

Controlled group

No interventions assigned to this group

Interventions

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Emergency surgical enterostomy

Emergency surgical enterostomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

0 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan Children's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Perforated HSCR

Identifier Type: -

Identifier Source: org_study_id

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