Nutrition Support for Hirschsprung Disease
A Multicentric Study on Pre-operative Nutritional Support for Hirschsprung's Disease
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedApril 4, 2023
April 1, 2023
1.8 years
October 18, 2020
April 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
rate of postoperative HAEC
Incidence of postoperative HAEC
3 months
Secondary Outcomes (4)
Z score
3 months
LOS
1 months
reoperation
3 months
readmission
3 months
Study Arms (2)
intervention group
EXPERIMENTALIntravenous nutrition or oral high-calorie diet 7-10 days before surgery
control group
NO INTERVENTIONnormal diet before surgery
Interventions
Special medical formula for the purpose of formula food
Eligibility Criteria
You may qualify if:
- Children aged 0-5 years.
- Clinical diagnosis with Hirschsprung's disease who requires surgery;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (1)
Tongji Hospital
Wuhan, Hubei, 430000, China
Related Publications (1)
Zhang HY, Chen K, Zhang Y, Gao T, Huang Y, Ge L, Yuan Y, Zhang G, Yang H, Ren H, Zhan J, Xu W, Liu X, Zhu T, Feng J. Preoperative nutritional support in children with Hirschsprung disease: a prospective multicenter open-label randomized controlled trial. Nat Commun. 2025 Dec 19;16(1):11171. doi: 10.1038/s41467-025-66541-x.
PMID: 41419466DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
October 18, 2020
First Posted
October 22, 2020
Study Start
January 1, 2021
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
April 4, 2023
Record last verified: 2023-04