NCT02102659Unknown不适用
This Preliminary Study Was Designed to Explore a New Biological Method for Nutritional Assessment by Measuring Oral Mucosal Epithelial Cell Apoptosis Rate and Guideline to Clinical Nutrition Support Therapy for Improving Clinical Outcome of Malnourished Patients.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- The Length and Width of Surgical Incision Edema
研究概览
简要总结
- Clinical nutritional support therapy is an important progress of modern medicine.
- Conventional methods of clinical nutrition assessment (Anthropometric, lab, etc.) not just lack of accuracy and immediacy but also difficult to dynamically reflect the fluctuation trend of nutrition status.
- It has been reported that malnutrition affects proliferation and apoptosis of human cells in vivo. This preliminary study was initiated by the hypothesis that changes in nutritional status may be reflected rapidly in fast proliferating cells.
- In the previous studies the investigators already found that apoptosis rate of oral mucosal epithelium could reflect changes in nutritional status.There were an obvious decreasing in apoptosis and proliferation rate of oral mucosal epithelium in malnourished patients.
- Based on the patient's curve of apoptosis rate of oral mucosal epithelium, the plateau being achieved by increase the nutrition amount continuously, Maintain this amount of nutrition given until the end of treatment. The investigators call this amount of nutrition the "upper limit nutrition support therapy".
- The patients applying for"upper limit nutrition support therapy" and "Formula nutrition support therapy" separately, comparing of the two methods influences on postoperative wound healing, postoperative complication rate ,inflammatory response, side effects of chemotherapy, hospital stays and hospitalization expenses.
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Gastric cancer or colorectal cancer which confirmed by Preoperative pathology will be included.
- •Patients who are diagnosed as malnutrition according history, physical examination and Nutrition Risk Screening 2002 will be included.
- •patients who have digestive tract fistula because of operation complication will be included.
- •patients who need fast track recovery after colorectal cancer operation will be included.
排除标准
- •Patients who are diagnosed as Late stage (stage IV) gastric cancer or colorectal cancer and can not accomplish radical resection will be excluded.
- •Postoperative gastric cancer or colorectal cancer patients who is Unable to tolerate the chemotherapy or unable to complete the whole chemotherapy course will be excluded.
- •patients with Severe endocrine system disease such as diabetic mellitus, hyperthyroidism will be excluded.
- •patients with cardiac, renal, respiratory, or hepatic diseases, diabetes,active infection, evidence of sepsis, active bleeding or obstruction, and oral disease will be excluded.
研究组 & 干预措施
Formula Nutrition Support Therapy
Active Comparator
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.
干预措施: Formula Nutrition Support Therapy (Genetic)
Upper Limit Nutrition Support Therapy
Experimental
"Upper limit nutrition support therapy" will be used in patens assigned to this group based on the patient's curve of apoptosis of oral mucosal epithelium.
干预措施: Upper Limit Nutrition Support Therapy (Genetic)
结局指标
主要结局
The Length and Width of Surgical Incision Edema
时间窗: 9th day
The length and width of surgical incision edema will be measured by doppler ultrasonography in the 9th day respectively after gastrointestinal operation.
The Length and Width of Surgical Incision Edema
时间窗: 2nd day
The length and width of surgical incision edema will be measured by doppler ultrasonography in the 2nd day respectively after gastrointestinal operation.
次要结局
- Oral Mucosal Epithelial Cell Apoptosis Rate(10 or 12 days)
- The level of serum proteins(9 days)
- Anthropometric measurements(9 days)
研究者
Jianping Gong
Director of Department of General Surgery
Huazhong University of Science and Technology
研究点 (1)
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