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临床试验/NCT01910948
NCT01910948Unknown4 期

Efficacy of Perioperative Application of Omega-3 Polyunsaturated Fatty Acids on Postoperative Immunization in Gastric Cancer Patients - A Prospective, Randomized Clinical Trial

Jian Suo0 个研究点目标入组 100 人开始时间: 2013年6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
100
主要终点
blood immune factors

研究概览

简要总结

To evaluate immunomodulatory effects of perioperative application of omega-3 polyunsaturated fatty acids in gastric cancer surgery, the effects of postoperative recovery, the improvement of nutritional status, incidence rate of related complications, and whether it can reduce the average postoperative hospitalization days.

详细描述

Methods: Choose from 6 to 2013-2013-12 gastric cancer patients, according to inclusion criteriaS to choose the objectS of study from the gastric cancer patients coming to our hospital 2013-06 to 2013-12 .The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add Omega-3 Polyunsaturated Fatty Acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add Omega-3 Polyunsaturated Fatty Acids 0.2 g/kg. Detect and compare CRP、TNF-α、IL-1、IL-4、lL-6、 IL-8、lL-10 levels of two groups in days before parenteral nutrition and applicating 3rd day and postoperative 1st, 3rd, 5th,and detect liver function in preoperative and postoperative 2nd,5th,7th day. Record postoperative anal exhaust time, postoperative complications, postoperative hospital days, preoperative and postoperative body weight.Results: Trail group patients compared with the control group,Omega-3 Polyunsaturated Fatty Acids can reduce early postoperative inflammatory cytokines release, reduce the postoperative fever time, reduce the incidence of systemic inflammatory response syndrome, promote the recovery of gastrointestinal function, improve the nutritional state of patients, reduce infection and related complications after the surgery and reduce postoperative hospitalization days. Conclusions: Perioperative application of omega 3 PUFA can reduce the release of inflammatory cytokines, regulating cell and humoral immunity, reduce the postoperative fever time, reduce the local inflammation medium that inhibit the gastrointestinal peristalsis, promote the recovery of gastrointestinal function, improve the nutritional state of patients, thereby reducing the occurrence of postoperative infection and related complications, reduce postoperative hospitalization days.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients coming to FirstJilinU diagnosed gastric cancer by endoscopy and pathology.
  • No preoperative treatment, the gastric cancer radical surgery in our hospital is the first treatment.
  • Nutrition screening score (NRS 3 or higher).
  • Albumin and (or) immune enhancer were not used within two weeks before operation .
  • No blood system diseases.

排除标准

  • Being in the acute phase of inflammation before operation and emergency surgery.
  • Patients combined metabolic diseases such as diabetes, hyperthyroidism, immune system disease or taking immunosuppressants;
  • Combined hepatic insufficiency.
  • Spleen resected in operation

研究组 & 干预措施

omega-3 polyunsaturated fatty acids

Experimental

The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add omega-3 polyunsaturated fatty acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add omega-3 polyunsaturated fatty acids 0.2 g/kg.

干预措施: omega-3 polyunsaturated fatty acids (Drug)

结局指标

主要结局

blood immune factors

时间窗: 10 days

次要结局

未报告次要终点

研究者

发起方
Jian Suo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jian Suo

Headmaster, Dept.of General Surgery

The First Hospital of Jilin University

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