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临床试验/NCT01778166
NCT01778166Unknown4 期

Immuno-enhanced Versus Standard Early Enteral Nutrition Use in Gastrointestinal Postoperative Patients

Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
200
试验地点
1
主要终点
Time to tolerate IEEN/SEEN

研究概览

简要总结

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Resectable gastric cancer by laparoscope
  • Resectable colorectal cancer laparoscope
  • Resectable gastrointestinal interstitialoma by laparoscope

排除标准

  • Locally unresectable tumor
  • Metastatic tumor
  • Preoperative total parenteral or enteral nutrition
  • Lack of the patient's consent for the trial participation
  • Previous gastrointestinal resection

研究组 & 干预措施

Standard early enteral nutrition

Active Comparator

There would be 100 patients in this group

干预措施: Standard early enteral nutrition (Drug)

Immuno-enhanced early enteral nutrition

Experimental

There would 100 patients in this group

干预措施: Immuno-enhanced (Drug)

结局指标

主要结局

Time to tolerate IEEN/SEEN

时间窗: 30 days after operation

次要结局

  • Overall morbidity rate of IEEN/SEEN(60 days after operation)
  • Mortality rate of IEEN/SEEN after operation(60 days after operation)
  • Energy metabolism(10 days after operation)
  • Time to the first postoperative adjuvant chemotherapy(30 days after operation)
  • Nutritional status in postoperative day1and 7 of IEEN/SEEN(7 days after operation)
  • Immune function in postoperative day 1 and 7(7 days after operation)
  • Postoperative hospital stay length(60 days after operation)
  • Rehospitalization rate(30 days after discharge)

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Danhua Yao

Senior Resident

Jinling Hospital, China

研究点 (1)

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