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临床试验/NCT04598841
NCT04598841已完成不适用

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

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
rate of postoperative HAEC

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
0 Years 至 5 Years(Child)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

intervention group

Experimental

Intravenous nutrition or oral high-calorie diet 7-10 days before surgery

干预措施: supplement nutritional supporting (Dietary Supplement)

control group

No Intervention

normal diet before surgery

结局指标

主要结局

rate of postoperative HAEC

时间窗: 3 months

Incidence of postoperative HAEC

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiexiong Feng

professor

Tongji Hospital

研究点 (1)

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