Nutrition Support for Hirschsprung Disease

Hirschsprung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598841
• Other study ID #: TJH-HSCRNS
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: April 2023
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 5 Years

Eligibility

Inclusion Criteria:

1. Children aged 0-5 years.

2. Clinical diagnosis with Hirschsprung's disease who requires surgery;

Exclusion Criteria:

1. Complicated with severe complications such as enterocolitis associated with Hirschsprung disease;

2. History of diseases associated with various organ systems that may be life-threatening;

3. Other severe digestive tract malformations or other diseases that may interfere with the treatment or compliance of the child;

4. Patients who have participated in other clinical trials within the last 1 month;

5. Any other conditions in which the investigator considers it inappropriate to participate in the trial.

Related Conditions & MeSH terms

• Hirschsprung Disease
• Infants
• Nutrition Supporting
• Prospective Study

Intervention

Dietary Supplement:
• supplement nutritional supporting
Special medical formula for the purpose of formula food

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of postoperative HAEC	Incidence of postoperative HAEC	3 months
Secondary	Z score	weight/age	3 months
Secondary	LOS	length of postoperative stay	1 months
Secondary	reoperation	rate of reoperation	3 months
Secondary	readmission	rate of readmission	3 months