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临床试验/NCT03877588
NCT03877588已完成不适用

Perioperative Nutritional and Hemodinamic Support in Retroperitoneal Sarcoma Patients. A Phase II Prospective Feasibility Study.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano0 个研究点目标入组 35 人开始时间: 2016年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
主要终点
Rate of Adherence to protocol

研究概览

简要总结

Prospective feasibility study of perioperative nutrition in patients affected by primary retroperitoneal sarcoma

详细描述

Aim of our study was to investigate the feasibility of a prehabilitation policy to optimize protein energetic reserves in a group of patients affected by primary localized RPS, candidate to a multiple organ resection surgery, as well as the feasibility of a standardized nutritional postoperative caloric target and its adequacy.

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Supportive Care
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

  • every patient with retroperitoneal sarcoma scheduled for surgery

排除标准

  • chronic renal failure
  • diabetes mellitus
  • emergency surgery
  • physical status classification system ASA>3
  • any contraindication to arterial catheter in Femoral artery for PICCO hemodynamic monitoring

研究组 & 干预措施

Primary retroperitoneal sarcoma

Other

All eligible patients are screened in preoperative phase, at least 30 days before surgery, for presence of protein energetic malnutrition (PEM). PEM is defined according to biochemical and physiological parameters (Table). 3 class of PEM are identified: no PEM, mild PEM and serious PEM. Different nutritional oral supplements are provided according to the degree of malnutrition.

干预措施: Oral Nutritional Support (Dietary Supplement)

结局指标

主要结局

Rate of Adherence to protocol

时间窗: 15 days

Rate of adherence to prescribed oral nutritional support

次要结局

未报告次要终点

研究者

发起方
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
申办方类型
Other
责任方
Sponsor

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