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临床试验/NCT06018246
NCT06018246已完成不适用

Effects of Different Nutritional Support Modes Based on Nutritional Risk Screening on Postoperative Nutritional Status of Patients With Gastrointestinal Cancer

The First Affiliated Hospital of Shanxi Medical University1 个研究点 分布在 1 个国家目标入组 624 人开始时间: 2021年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
624
试验地点
1
主要终点
Nutritional risk screening 2002

研究概览

简要总结

The goal of this clinical trial was to compare the effects of different nutritional support methods based on nutritional risk screening on postoperative nutritional status in patients with gastrointestinal tumors.The main question it aims to answer is that different types of nutrition can improve the nutritional status of patients with different nutritional status;Long-term dietary interventions for patients with poor nutrition can make cancer patients better able to tolerate surgery and chemotherapy and improve their quality of life.The intervention group received nutrition + exercise + psychological intervention upon admission, routine parenteral and enteral nutrition support after operation, and continued nutrition + exercise + psychological intervention after discharge.The control group received routine parenteral nutrition support in the department after surgery, and the patients and their families were given diet education during hospitalization.

详细描述

Purpose: The investigators conducted nutritional risk screening for patients with gastrointestinal tumors, gave different nutritional support methods to patients with different nutritional status, and analyzed the changes of various nutritional indexes of patients before and after nutritional intervention.

Methods: A total of 302 patients with gastrointestinal tumors admitted to the First Hospital of Shanxi Medical University from July 2021 to June 2023 were selected.All patients underwent nutritional risk screening after admission and were divided into intervention group (NRS2002≥3 and PG=SGA≥4, n=204) and control group (NRS2002 < 3 or PG=SGA < 4 , n=98) according to the screening results.Different nutritional interventions were given to analyze the changes of NRS-2002 and PG-SGA scores between the two groups before and after propensity score matching, and compare the changes of dietary energy, dietary protein, total energy, total protein, body mass index (BMI), fat-free weight, walking time, grip strength and other nutritional indicators (hemoglobin, albumin, prealbumin) between the two groups.The effects of disease type and age on the results were compared by stratified analysis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Age ≥ 18 years;
  • The first pathological diagnosis was gastric or colorectal cancer and radical resection of malignant tumor was performed;
  • Conscious, able to read, write and understand the study;
  • Sign informed consent and participate in this study voluntarily.

排除标准

  • Patients with malignant tumors at other sites;
  • Patients undergoing neoadjuvant chemotherapy before surgery;
  • Anastomotic fistula, anastomotic obstruction, gastroparesis and other serious complications occurred after operation;
  • There are mental disorders, psychological disorders;
  • Patients who did not cooperate to complete the full intervention or follow-up records were missing;
  • Patients with missing baseline data and nutritional risk screening results.

结局指标

主要结局

Nutritional risk screening 2002

时间窗: baseline and through study completion, an average of 1 year

Nutritional risk screening scale:The maximum score of NRS2002 is 7 points and the minimum score is 0 points. A score of NRS2002≥3 indicates the presence of nutritional risk, and nutritional support programs should be developed in combination with clinical practice. A score of NRS2002 \< 3 indicates no nutritional risk, and a review is performed 1 week later.

Patient-generated subjective nutrition assessment

时间窗: baseline and through study completion, an average of 1 year

Nutritional risk screening scale:0-1 score, no intervention is required at this time, regular regular nutritional status score. 2 to 3 points, the nutritionist, nurse or clinician to educate the patient and family, and appropriate drug intervention for symptoms and laboratory tests. 4-8 points, requiring nutritional intervention and symptomatic treatment. A score of ≥9 indicates an urgent need for symptomatic treatment and appropriate nutrient support.

次要结局

  • Nutrient protein intake(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Dietary energy intake(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Dietary protein intake(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Nutrient energy intake(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Hemoglobin(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Prealbumin(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Walking time(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Albumin(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • BMI(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Fat-free body weight(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Grip strength(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)

研究者

发起方
The First Affiliated Hospital of Shanxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang He

Chief physician of gastrointestinal surgery and Section chief of Medical Services Division

The First Affiliated Hospital of Shanxi Medical University

研究点 (1)

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