Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Body weight decrease rate 8weeks after discharge compared with preoperative body weight
研究概览
简要总结
Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption function, and/or metabolic changes after surgery. The postoperative malnutrition is associated with low quality of life and seems to be related long-term nutritional status. This study is a multicenter, open-labeled prospective randomized clinical trial to examine the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal surgery by comparing the change of body weight and other nutritional parameters between the experiment group that is supplied with ONS and the control group without ONS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female who are 20 or more years old and not more than 80 years old
- •Discharge from a hospital is planned within 2 weeks after major gastrointestinal surgery (except when ileostomy is performed)
- •oral intake is possible at the time of discharge
- •no preoperative chemotherapy or preoperative radiotherapy
- •voluntarily agreed with the informed consent of this clinical trial
排除标准
- •Intravenous or other specific nutritional treatment is needed
- •BMI >25 and postoperative weight loss is not > 5% of preoperative body weight at the time of discharge
- •Allergy to milk, whey, bean, salmon, or the investigational product
- •Residual of cancer in the abdominal cavity postoperatively if it is cancer case
- •Presence of synchronous other cancers that needs treatment.
- •When investigator judged that the patient is not eligible to the trial
结局指标
主要结局
Body weight decrease rate 8weeks after discharge compared with preoperative body weight
时间窗: 8weeks after discharge
次要结局
- Changes in body weight before and after surgery(preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge)
- Change of body mass index before and after surgery(preoperatively, at the time of discharge after surgery, and 8 weeks after discharge)
- changes in PG-SGA score and grade(preoperatively, and 2,4,8 weeks after discharge)
- serum hemoglobin(preoperatively, at the time of discharge, 2,4,8 weeks after discharge)
- serum total lymphocyte count(preoperatively, at the time of discharge, 2,4,8 weeks after discharge)
- serum total cholesterol(preoperatively, at the time of discharge, 2,4,8 weeks after discharge)
- serum total protein(preoperatively, at the time of discharge, 2,4,8 weeks after discharge)
- serum albumin(preoperatively, at the time of discharge, 2,4,8 weeks after discharge)