Investigating the effect of glutamine in colorectal surgery
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https://www.omicsdi.org/dataset/ecrin-mdr-crc/94053
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Intervention 1: Intervention group: They will receive glutamine powder (Karen Company) in the form of 30 grams per day for 10 days before surgery. Intervention 2: Control group: They will receive placebo with starch content (Karen Company) for 10 days before surgery.
Primary outcome(s): Carcinoembryonic antigen. Timepoint: At the beginning of the study (10 days before surgery), and one month after surgery. Method of measurement: Quantitative electroluminescence.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this experiment, the balanced random block method will be used, with a block size of 4 (combination of A and B as groups). Using the Randomization.com website, random allocation will be done for 200 people in the form of 50 blocks of 4. Since body mass index is an important variable in the intervention effect. This intervention will be implemented in a classified manner. In order to carry out this trial correctly, a random allocation list will be produced separately for each of the two classes of body mass index 18.5 to 25 and 25 to 30, Blinding description: One of the nurses will be responsible for randomly selecting patients and prescribing supplements for them. In order to carry out this research blindly, the supplements will be completely similar and closed in terms of appearance. Also, glutamine supplement and placebo are separated
干预1:试验组:受试者将在术前10天每日服用30克谷氨酰胺粉剂(Karen公司生产)。干预2:对照组:受试者将在术前10天服用含淀粉的安慰剂(Karen公司生产)。
主要结局指标:癌胚抗原(Carcinoembryonic antigen)。检测时间点:研究开始时(术前10天)及术后1个月。检测方法:定量电化学发光法(Quantitative electroluminescence)。
试验设计:随机化方式:随机分配,设盲方式:双盲,使用安慰剂,分组方式:平行分组,试验目的:预防。随机化说明:本试验采用平衡区组随机法,区组长度为4(以A、B组合作为区组)。通过Randomization.com网站为200名受试者生成50个区组(每个区组4人)的随机分配方案。鉴于体重指数是影响干预效应的重要变量,本试验将按体重指数分层实施。为确保试验规范开展,将分别为体重指数18.5~25及25~30两个分层亚组生成独立的随机分配列表。设盲说明:将由一名护士负责筛选受试者并开具研究用制剂。为保证试验盲法顺利实施,研究用制剂在外观上完全一致且采用密闭包装。此外,谷氨酰胺补充剂与安慰剂将分开存放。
创建时间:
2023-07-15



