【ChiCTR1900020628】全肠内营养在克罗恩病患者腹腔镜手术中的作用

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基本信息

登记号

ChiCTR1900020628

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2019-01-10

临床申请受理号

靶点

适应症

克罗恩病

试验通俗题目

全肠内营养在克罗恩病患者腹腔镜手术中的作用

试验专业题目

全肠内营养在克罗恩病患者腹腔镜手术中的作用

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

310016

联系人通讯地址

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临床试验信息

试验目的

术前全肠内营养对克罗恩病腹腔镜手术术后并发症的影响

试验分类

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试验类型

队列研究

试验分期

回顾性研究

随机化

此研究为回顾性研究

盲法

N/A

试验项目经费来源

国家自然科学基金（81800474）

试验范围

目标入组人数

120

实际入组人数

第一例入组时间

2019-01-11

试验终止时间

2020-12-31

是否属于一致性

入选标准

(1) radiologic, endoscopic, and histologic diagnosis of CD according to ESPEN guidelines(9); (2) CD patients required a laparoscopic approach for bowel resection; (3) the score of Nutritional Risk Screening (NRS-2002) was more than 2; (4) for the EEN group, patients had EEN therapy for at least 4 weeks before surgery by nasogastric tube, and the daily calorie intake was 25-30 kcal/kg of body weight; (5) for the non-EEN group, patients received a liquid diet, semiliquid diet, oral enteral nutrition, or intravenous solution to improve their nutrition status and maintain their water-electrolyte balance; (6) patients received other preoperative optimization, such as quitting smoking, and stopping corticosteroid treatment before surgery. Patients with incomplete laboratory data, poor compliance with EEN therapy, or multivisceral resection were excluded. In our hospital, CD patients were always encouraged to receive nutrition treatment before surgery, but whether or not patients accepted a nasogastric tube were their decisions.；

排除标准

The exclusive enteral nutrition used in this study before the surgery was Peptison liquid (Nutricia, Amsterdam, Netherlands), which was composed of vitamins, minerals, hydrolyzed whey protein peptide, trace elements, very little fat, vegetable oil, and maltodextrin(16). The content of major nutrients included carbohydrates (17.6 grams), lipids (1.7 grams), and protein (4 grams) per 100 mL of liquid. The calorie density was 1 kcal/mL with an osmolarity of 440 mosm/L.；

研究者信息

研究负责人姓名

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试验机构

浙江大学医学院附属邵逸夫医院

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

310016

联系人通讯地址