A RANDOMIZED, CONTROLLED, CLINICAL TRIAL TO COMPARE PERIPHERAL PARENTERAL NUTRITION (PeriOlimel N4-E) VERSUS CONVENTIONAL FLUID THERAPY IN ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL IN COLORECTAL CANCER SURGERY.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- morbi-mortality
研究概览
简要总结
Assess if administration of early nutrition support with Perioperative Peripheral Nutrition (PeriOliclimonel) N4-E) in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery (ERAS) Protocol improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy.
详细描述
The main objective is to determine if perioperative nutritional support with PeriOlimel N4-E, that reaches nutritional requirements of ERAS protocol for colorectal cancer surgery patients, can improve nutritional status so it decreases postoperative complications, hospital length of stay and costs, compared to conventional fluid therapy administration since patients receive oral nutrition at day 3-5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •scheduled colorectal cancer surgery
排除标准
- •Emergency surgery
- •Distant metastasis
- •Patient´s refusal to participate
- •Allergy or hypersensitivity to egg or soy protein
- •Advanced kidney or hepatic impairment
- •Severe bleeding disorders
- •Congenital abnormalities of amino acid metabolism
- •Hyperlipidemia and severe or difficult to control hyperglycemia
研究组 & 干预措施
Perioperative peripheral parenteral nutrition
Perioperative peripheral parenteral nutrition during 4 days
干预措施: Perioperative peripheral parenteral nutrition (Drug)
结局指标
主要结局
morbi-mortality
时间窗: 30 days
Early Peripheral Parenteral Nutrition in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery Protocol to improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy
次要结局
未报告次要终点
研究者
Antonio Arroyo Sebastian
Principal Investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana