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临床试验/NCT02647476
NCT02647476已完成3 期

The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients

Jagiellonian University2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2004年11月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
98
试验地点
2
主要终点
Postoperative complication rate

研究概览

简要总结

Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.

The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.

The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

详细描述

Treatment of gastric cancer often requires major surgery and carries the risk of postoperative complications and fatal outcomes. Mortality rates after gastrectomy due to gastric cancer have been reported as 2-5%, while the incidence of postoperative complications was 10 to over 40%.

Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.

The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.

The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 or standard enteral nutrition n=54. Following the initial randomization, the patients received either standard nutrition (oligopeptide, low-fat, isocaloric, non-residue diet - Peptisorb, Nutricia) or immunomodulating nutrition (protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • gastric cancer confirmed in histopathological examination
  • elective operation due to gastric cancer
  • informed consent signed
  • age > 18 years
  • normal nutritional status or mild to moderate malnutrition

排除标准

  • severe malnutrition which required parenteral nutrition
  • urgent operation

研究组 & 干预措施

Study group

Experimental

Immunomodulating nutrition (Reconvan)

干预措施: Immunomodulating nutrition (Reconvan) (Dietary Supplement)

Control group

Active Comparator

Standard nutrition (Peptisorb)

干预措施: Standard nutrition (Peptisorb) (Dietary Supplement)

结局指标

主要结局

Postoperative complication rate

时间窗: 30 days

Complication rate during 30 days after the operation

次要结局

  • Overall survival(5 years)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Radoslaw Pach, MD, Ph D

Assisstant Professor

Jagiellonian University

研究点 (2)

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