CTRI/2025/07/091351招募中不适用
Effect of perioperative enteral ecoimmunonutrition on postoperative morbidity in patients undergoing curative gastrointestinal cancer surgeries – a double blind Randomized Controlled Trial
Dr Reshmi Suresh1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年8月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Rate of postoperative infectious complications
研究概览
简要总结
This study is a randomised double blinded parallel group, single centre trial, comparing the effect of perioperative enteral ecoimmunonutrition vs placebo on postoperative morbidity in 110 patients undergoing curative gastrointestinal cancer surgeries in AIIMS Bhubaneswar , India. The primary outcomes will be postoperative infectious complications in 30 days. The secondary outcomes will be nutritional status, inflammatory status by 4th postoperative day and non infectious complications , recovery by 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All cases of gastrointestinal malignancies undergoing curative elective surgeries in the department of surgical oncology, AIIMS Bhubaneswar.
- •2.Eastern Cooperative Oncology Group score less than
- •3.Patients willing to consent for participating in the study.
排除标准
- •1.Gastric outlet obstruction, intestinal obstruction undergoing emergency surgery.
- •2.Sepsis 3.Renal failure and hepatic failure 4.Psychiatric illness.
结局指标
主要结局
Rate of postoperative infectious complications
时间窗: 30 days
次要结局
- Anemia, hypoalbuminemia, inflammatory status.(2 and 4th day of postoperative period)
- non infectious complications, duration of postoperative hospital stay, recovery.(30 days)
研究者
Dr Reshmi Suresh
All India Institute of Medical Sciences, Bhubaneswar
研究点 (1)
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