Nutritional Support for Patients Operated on for Malignant Tumors of the Hepatico-pancreato-duodenal (HPD) Zone in the Early Postoperative Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Total protein level in Blood
研究概览
简要总结
A comprehensive comparative analysis of the effectiveness of isolated enteral, isolated parenteral and mixed type of nutritional support in the early postoperative period in patients after operations performed on the malignant neoplasms of hepatico-pancreatico-duodenal zone.
详细描述
A prospective, longitudinal, parallel study and retrospective analysis of the results of treatment of 91 patients with malignant tumors of the hepatico-pancreato-duodenal zone who underwent the following operations:
- resection of various segments of the liver;
- hemihepatectomy;
- transhepatic drainage of the right and left hepatic duct;
- bypass gastroenteroanastomosis or cholecystenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
- gastro-pancreato-duodenal resection;
- corpore-caudal resection of the pancreas with splenectomy.
The first group (n=31) included patients who received enteral nutrition (EN) after surgery. The second group (n=30) included patients who received parenteral nutrition (PN) and the third group (n=30) who received mixed nutrition (MN), as a variation of the partial parenteral nutrition technique, in the early postoperative period.
Some nutritional status indicators available for determination at the Oncology Clinic were assessed - body mass index (weight measurements were carried out before surgery, on the 5th, 10th and 15th days), basal metabolic rate (calculated using the Harris-Benedict equation, based on anthropometric data of the patient (gender, age, weight and height).), laboratory parameters: blood hemoglobin, lymphocytes, total protein, serum albumin, serum transferrin, total bilirubin and direct, alanine aminotransferase (ALT), aspartate aminotransferase (AST), which are related to the traditional method for assessing nutritional status
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •female and male patients in age of 20-75 with malignant tumors of the hepato-pancreato-duodenal zone who have undergone any of the following operations:
- •resection of various segments of the liver;
- •hemihepatectomy;
- •transhepatic drainage of the right and left hepatic duct;
- •bypass gastroenteroanastomosis or cholecystoenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
- •gastro-pancreatoduodenal resection;
- •corporecaudal resection of the pancreas with splenectomy.
排除标准
- •patients in age of up to 20 and older than 75
- •pregnant and breastfeeding women
结局指标
主要结局
Total protein level in Blood
时间窗: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: total protein in g/L
ALT in IU/L
时间窗: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: ALT in IU/L
AST in IU/L
时间窗: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: AST in IU/L
Number of Participants with changes of BMI in kg/m^2
时间窗: Day 0, Day 5, Day 10, Day15
Variables of Body mass index measured by Canadian Guidelines for Body Weight Classification in Adults
Serum transferrin in g/L
时间窗: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: serum transferrin in g/L
Serum albumin in g/L
时间窗: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: serum albumin in g/L
Total bilirubin in mmol/L
时间窗: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: total bilirubin in mmol/L
Direct bilirubin in mmol/L
时间窗: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: direct bilirubin in mmol/L
Basal Metabolic rate
时间窗: Day 0, Day 5, Day 10, Day15
basal metabolic rate according to the Harris-Benedict equation
次要结局
未报告次要终点