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Clinical Trials/NCT04598841
NCT04598841
Completed
Not Applicable

A Multicentric Study on Pre-operative Nutritional Support for Hirschsprung's Disease

Tongji Hospital1 site in 1 country110 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutrition Supporting
Sponsor
Tongji Hospital
Enrollment
110
Locations
1
Primary Endpoint
rate of postoperative HAEC
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

A multi-center, prospective,randomized, non-blind, controlled study was conducted to investigate the effects of different pre-operative nutritional support modes on perioperative nutritional status, surgical treatment success rate, and rehabilitation process in children with Hirschsprung disease.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
October 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jiexiong Feng

professor

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • Children aged 0-5 years.
  • Clinical diagnosis with Hirschsprung's disease who requires surgery;

Exclusion Criteria

  • Complicated with severe complications such as enterocolitis associated with Hirschsprung disease;
  • History of diseases associated with various organ systems that may be life-threatening;
  • Other severe digestive tract malformations or other diseases that may interfere with the treatment or compliance of the child;
  • Patients who have participated in other clinical trials within the last 1 month;
  • Any other conditions in which the investigator considers it inappropriate to participate in the trial.

Outcomes

Primary Outcomes

rate of postoperative HAEC

Time Frame: 3 months

Incidence of postoperative HAEC

Secondary Outcomes

  • Z score(3 months)
  • LOS(1 months)
  • reoperation(3 months)
  • readmission(3 months)

Study Sites (1)

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