A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 358
- 试验地点
- 2
- 主要终点
- Change from preoperative weight change at postoperaive 12 months in SE and IE groups.
研究概览
简要总结
Radical gastrectomy has been known as the most effective treatment of curable gastric cancer.However, there is a high risk of malnutrition and weight loss after a gastrectomy which may be attributed to inadequate oral consumption, malabsorption and loss of the reservoir function of the stomach.Weight loss has been regarded as an independent risk factor for postoperative mortality and morbidity and It is also closely associated with a quality of life after surgery. No specific surgical technique has been proved to be effective in reducing postoperative weight loss and it seems like that dietary education and consultation is the best way to minimize weight loss in gastrectomy patients in clinical setting. In this regard, the investigators performed a retrospective pilot study to identify the effect of routinely performed (simplified) dietary education on nutritional status after gastrectomy, but it revealed that the effect of simplified dietary education on weight loss was not clear and the result implies that more intensive dietary education may be necessary after gastrectomy. The aim of this randomized controlled trial (RCT) is to elucidate the effect of intensive dietary education on nutritional status after gastrectomy in comparison with simplified dietary education.
详细描述
Subject 1: subtotal gastrectomy group
subject 2: total gastrectomy group
Objectives:
Primary objective: to evaluate Weight loss difference of simplified dietary education(SE) versus intensive dietary education(IE) for patients after undergoing a gastrectomy
Primary endpoint: Superiority of weight loss difference (%) of IE group between post op 1mo and 12mo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven primary gastric adenocarcinoma,
- •T1N0, T1N1, T2N0, which are assessed by computed tomography (CT) scan (AJCC 8th classification) and intraoperative surgical staging
- •location of primary tumor; antrum, or angle, , lower body or mid body of the stomach
- •No evidence of other distant metastasis,
- •age ≥ 20 year old, ≤ 75 year old
- •no prior or posterior treatment of chemotherapy or radiation therapy against any other malignancies
- •adequate organ functions defined as indicated below:
- •WBC count: 3000/mm3 ~12,000/mm3,
- •> serum Hemoglobin 8.0 g/dL
- •> serum Platelet 100 000/mm3,
- •< serum AST 100 IU/L,
- •<serum ALT 100 IU/L,
- •< Total Bilirubin 2.0 mg/dL,
- •written signed informed consent
排除标准
- •active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer),
- •gastric remnant cancer
- •≥T3, T4 in surgical staging before resection
- •N2 or more (number of metastatic lymph nodes ≥3) in CT scan
- •histologically rare variants in World Health Organization (WHO) Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, neuroendocrine carcinoma and others
- •pregnant or breast-feeding women,
- •mental disorder(diagnosed with mental disorder on medical record),
- •unstable angina or myocardial infarction within 6 months of the trial,
- •unstable hypertension,
- •diabetes mellitus on insulin,
- •severe respiratory disease requiring continuous oxygen therapy,
- •previous upper abdominal surgery except laparoscopic cholecystectomy,
- •surgical complication
结局指标
主要结局
Change from preoperative weight change at postoperaive 12 months in SE and IE groups.
时间窗: preoperative, postoperative 12 months
comparison of weight change between the two groups after surgery
Change from preoperative weight change at immediate postoperative period in SE and IE groups.
时间窗: preoperative, immediate postoperative
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 6 months in SE and IE groups.
时间窗: preoperative, postoperative 6 months
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 1 month in SE and IE groups.
时间窗: preoperative, postoperative 1 month
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 3 months in SE and IE groups.
时间窗: preoperative, postoperative 3 months
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 18 months in SE and IE groups.
时间窗: preoperative, postoperative 18 months
comparison of weight change between the two groups after surgery
次要结局
- 24hrs dietary recall(preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months)
- Nutritional parameters(preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months)
- Quality of life of the patients(preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months)
- Albumin(preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months)
- Ferritin(preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months)
- Hemoglobin(preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months)
- Vitamin B12(preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months)
- dietary habits(preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months)
- Total iron binding capacity (TIBC)(preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months)
- Absolute lymphocyte count (ALC)(preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months)
- Homocysteine(preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months)
研究者
Jae Moon Bae
Professor
Samsung Medical Center