Gastrointestinal Postoperative Early Enteral Nutrition: Immuno-enhanced Versus Standard Early Enteral Nutrition (ISEEN)
Immuno-enhanced Versus Standard Early Enteral Nutrition Use in Gastrointestinal Postoperative Patients
Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and suppressed immune function, which might be worsened by major elective surgery.Enteral nutrition has been emphasized for patients with GI malignancy during the perioperative period to accelerate bowel function recovery, and improve nitrogen balance and immune response while reducing postoperative complications and hospitalization time.Early enteral nutrition(EEN) can promote the postoperative recovery of GI function and has been considered to have other advantages such as the reduction of medical cost and maintenance of intestinal barrier function. Immunonutrition containing special compounds like omega-3-unsaturated fatty acids has been put forward to modulate the immune response and improve the immune function in patients with cancer, which may have an better effect on the immune system than standard enteral nutrition. However, studies on immuno-enhanced early enteral nutrition after a resectable GI malignancy surgery are scarce.
The aim of this study was to determine whether immuno-enhanced early enteral nutrition(IEEN) is more effective than standard early enteral nutrition(SEEN) on nutritional status, immune function, surgical outcomes,time to adjuvant chemotherapy and days of hospitalization after laparoscopic GI surgery.
研究概览
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Jiangsu
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Nanjing、Jiangsu、中国、210002
- Jinling Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Resectable gastric cancer by laparoscope
- Resectable colorectal cancer laparoscope
- Resectable gastrointestinal interstitialoma by laparoscope
Exclusion Criteria:
- Locally unresectable tumor
- Metastatic tumor
- Preoperative total parenteral or enteral nutrition
- Lack of the patient's consent for the trial participation
- Previous gastrointestinal resection
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Standard early enteral nutrition
There would be 100 patients in this group
|
Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C standard enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube
|
|
实验性的:Immuno-enhanced early enteral nutrition
There would 100 patients in this group
|
Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid concerning omega-3-unsaturated fatty acids 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Time to tolerate IEEN/SEEN
大体时间:30 days after operation
|
30 days after operation
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
能量代谢
大体时间:术后10天
|
术后10天
|
|
术后住院时间
大体时间:术后60天
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术后60天
|
|
再住院率
大体时间:出院后30天
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出院后30天
|
|
Overall morbidity rate of IEEN/SEEN
大体时间:60 days after operation
|
60 days after operation
|
|
Mortality rate of IEEN/SEEN after operation
大体时间:60 days after operation
|
60 days after operation
|
|
Time to the first postoperative adjuvant chemotherapy
大体时间:30 days after operation
|
30 days after operation
|
|
Nutritional status in postoperative day1and 7 of IEEN/SEEN
大体时间:7 days after operation
|
7 days after operation
|
|
Immune function in postoperative day 1 and 7
大体时间:7 days after operation
|
7 days after operation
|
合作者和调查者
调查人员
- 首席研究员:Danhua Yao, MD/PhD、Nanjing university
出版物和有用的链接
一般刊物
- Osland E, Yunus RM, Khan S, Memon MA. Early versus traditional postoperative feeding in patients undergoing resectional gastrointestinal surgery: a meta-analysis. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):473-87. doi: 10.1177/0148607110385698. Epub 2011 May 31.
- Liu H, Ling W, Shen ZY, Jin X, Cao H. Clinical application of immune-enhanced enteral nutrition in patients with advanced gastric cancer after total gastrectomy. J Dig Dis. 2012 Aug;13(8):401-6. doi: 10.1111/j.1751-2980.2012.00596.x.
- Felekis D, Eleftheriadou A, Papadakos G, Bosinakou I, Ferekidou E, Kandiloros D, Katsaragakis S, Charalabopoulos K, Manolopoulos L. Effect of perioperative immuno-enhanced enteral nutrition on inflammatory response, nutritional status, and outcomes in head and neck cancer patients undergoing major surgery. Nutr Cancer. 2010;62(8):1105-12. doi: 10.1080/01635581.2010.494336.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ISEEN001
- ISEEN (注册表标识符:ISEEN)
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