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临床试验/NCT04692545
NCT04692545已完成不适用

Preoperative Immunonutrition Versus Standard Dietary Advice in Normo-nourished Patients Undergoing Fast-track Laparoscopic Colorectal Surgery

University of Rome Tor Vergata0 个研究点目标入组 173 人开始时间: 2016年12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
173
主要终点
Length of hospital stay

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 colorectal cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic surgery 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

  • laparoscopic colorectal resection for cancer following ERAS protocol
  • >18 years old
  • elective setting

排除标准

  • age below 18
  • malnutrition
  • inflammatory bowel disease
  • acquired or congenital immunodeficiency
  • preoperative infection
  • pregnancy
  • emergency setting
  • conversion to open surgery
  • multivisceral resections

结局指标

主要结局

Length of hospital stay

时间窗: up to 30 days after discharge

number of days between primary colorectal resection and discharge

次要结局

  • 30-days Mortality(up to 30 days after discharge)
  • Pneumonia(up to 30 days after discharge)
  • Time to postoperative food intake(up to 30 days after discharge)
  • Time to first defecation(up to 30 days after discharge)
  • 30-days postoperative complications(up to 30 days after discharge)
  • Surgical site infection(up to 30 days after discharge)
  • Anastomotic leak(up to 30 days after discharge)
  • Readmission(up to 90 days after discharge)
  • Ileus(up to 30 days after discharge)
  • Prolonged length of stay(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

MD, PhD, Associate Professor

University of Rome Tor Vergata

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