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NCT05044741 Clinical Trial

Risk Factors of Perforated HSCR in Neonates

Hirschsprung Disease Clinical Trial

Official title:
The Risk Factors for Bowel Perforation in Neonates With Hirschsprung Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05044741
Other study ID # Perforated HSCR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2006
Est. completion date December 31, 2019

Study information
Verified date August 2021
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date December 31, 2019
Est. primary completion date December 31, 2010
Accepts healthy volunteers No
Gender All
Age group N/A to 30 Days
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Emergency surgical enterostomy
Emergency surgical enterostomy

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Tongji Hospital The First Affiliated Hospital of Zhengzhou University, Wuhan Children's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of bowel perforation in neonatal Hirschsprung disease (perforated HSCR) Cases with bowel perforation in neonatal Hirschsprung disease/ total neonatal Hirschsprung disease 14 years
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