Risk Factors of Perforated HSCR in Neonates

NCT05044741 | Completed

• 1 other identifier: Perforated HSCR
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hirschsprung Disease; Bowel; Perforation, Fetus or Newborn

Outcome Measures

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

  14 years

Study Arms (2)

Perforated group

Procedure: Emergency surgical enterostomy

Controlled group

Interventions

Emergency surgical enterostomy PROCEDURE

Emergency surgical enterostomy

Perforated group

Eligibility Criteria

• Age: 0 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead
• Wuhan Children's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 16, 2021
• Study Start: January 1, 2006
• Primary Completion: December 31, 2010
• Study Completion: December 31, 2019
• Last Updated: September 16, 2021

Record last verified: 2021-08