Risk Factors of Perforated HSCR in Neonates

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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Key information

Conditions

Hirschsprung Disease Bowel; Perforation, Fetus or Newborn Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Megacolon

Age range

0 day–30 day

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emergency surgical enterostomy

Procedure

Emergency surgical enterostomy

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

The First Affiliated Hospital of Zhengzhou University
Wuhan Children's Hospital

Registry information

Official study title

The Risk Factors for Bowel Perforation in Neonates With Hirschsprung Disease

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2019
First posted: Sep 16, 2021
Registry last updated: Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed