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
- 否
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
Giuseppe Sigismondo Sica
Prof
University of Rome Tor Vergata
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