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临床试验/NCT05259488
NCT05259488已完成不适用

Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy: a Single-centre Comparative Study

University of Rome Tor Vergata0 个研究点目标入组 51 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
主要终点
30-days postoperative complications

研究概览

简要总结

Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after gastrointestinal surgery. More specifically, it seems to be beneficial also in gastric cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic total gastrectomy are yet to be determined.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • Age >18 years
  • Primary gastric cancer
  • Preoperative staging I-III
  • Eligible for laparoscopic D2 total gastrectomy

排除标准

  • Acquired or congenital immunodeficiency
  • Malnutrition (MNA-SF score < 12)
  • Preoperative infection
  • Previous gastric surgery
  • Emergency setting
  • Para-aortic node involvement
  • Intraoperative evidence of distant metastasis or peritoneal carcinosis
  • Conversion to open surgery

结局指标

主要结局

30-days postoperative complications

时间窗: up to 30 days after discharge

Rate of any complication after colorectal resection

LOS

时间窗: up to 30 days after discharge

number of days between primary colorectal resection and discharge

次要结局

  • Prolonged length of stay(up to 30 days after discharge)
  • Readmission(up to 30 days after discharge)
  • Mortality(up to 30 days after discharge)
  • Time of first defacation(up to 30 days after discharge)
  • Pneumonia(up to 30 days after discharge)
  • Anastomotic leak(up to 30 days after discharge)
  • Ileus(up to 30 days after discharge)
  • Time of tolerated fluid intake(up to 30 days after discharge)
  • Time of tolerated food intake(up to 30 days after discharge)

研究者

发起方
University of Rome Tor Vergata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Sigismondo Sica

Prof

University of Rome Tor Vergata

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