NCT04598841CompletedNot Applicable
A Multicentric Study on Pre-operative Nutritional Support for Hirschsprung's Disease
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tongji Hospital
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- rate of postoperative HAEC
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
intervention group
Experimental
Intravenous nutrition or oral high-calorie diet 7-10 days before surgery
Intervention: supplement nutritional supporting (Dietary Supplement)
control group
No Intervention
normal diet before surgery
Outcomes
Primary Outcomes
rate of postoperative HAEC
Time Frame: 3 months
Incidence of postoperative HAEC
Secondary Outcomes
- LOS(1 months)
- reoperation(3 months)
- readmission(3 months)
- Z score(3 months)
Investigators
Jiexiong Feng
professor
Tongji Hospital
Study Sites (1)
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