Risk Factors of Perforated HSCR in Neonates

September 5, 2021 updated by: Tongji Hospital

The Risk Factors for Bowel Perforation in Neonates With Hirschsprung Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Perforated group
Procedure: Emergency surgical enterostomy
Emergency surgical enterostomy
Controlled group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Actual)

December 31, 2010

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

September 5, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perforated HSCR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Until now, we do not have the plan to open individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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