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临床试验/NCT07104175
NCT07104175已完成不适用

Value Analysis of Preoperative Nutritional Risk Screening 2002 (NRS2002) and Global Leadership Initiative on Malnutrition (GLIM) Screening in Predicting Postoperative Complications in Patients With Gastrointestinal Malignancies

Third central hospital of Tianjin affiliated Nankai university1 个研究点 分布在 1 个国家目标入组 471 人开始时间: 2019年12月1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
471
试验地点
1
主要终点
Incidence of Postoperative Complications

研究概览

简要总结

This prospective cohort study investigates and compares the predictive power of two nutritional assessment tools, the Nutritional Risk Screening 2002 (NRS2002) and the Global Leadership Initiative on Malnutrition (GLIM) criteria. The study aims to determine how well these tools can predict postoperative complications in patients with gastrointestinal malignancies who are undergoing surgical resection.

详细描述

Malnutrition is a common and severe problem in patients with gastrointestinal (GI) malignancies, adversely affecting surgical outcomes. This prospective cohort study was designed to evaluate and compare the predictive utility of two key nutritional assessment tools. Patients scheduled for elective curative-intent surgery for GI malignancies were enrolled. Within 24 hours of admission, each patient's nutritional status was assessed using both the Nutritional Risk Screening 2002 (NRS2002) and the Global Leadership Initiative on Malnutrition (GLIM) criteria. The study followed these patients through their hospital stay and post-discharge to collect data on the primary outcome of postoperative complications, as well as secondary outcomes including length of hospital stay, hospitalization costs, and unplanned 30-day and 60-day readmissions. The objective is to provide evidence to guide clinicians in using NRS2002 and GLIM for preoperative risk stratification and to identify patients who may benefit from nutritional interventions to improve surgical outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Age ≥ 18 years.
  • •Histopathologically confirmed primary gastrointestinal malignancy (e.g., esophageal, gastric, colorectal cancer).
  • •Planned curative-intent surgical resection.
  • •No prior anti-tumor treatments such as surgery, radiotherapy, chemotherapy, or immunotherapy for the current malignancy.
  • •Provision of written informed consent to participate in the study.

排除标准

  • •Presence of other concurrent systemic malignant tumors.
  • •Emergency surgery.
  • •Hospital stay less than 48 hours post-surgery.
  • •Incomplete critical clinical or nutritional data.
  • •Refusal to participate.

结局指标

主要结局

Incidence of Postoperative Complications

时间窗: Up to 30 days post-surgery

Measured as the number of patients experiencing one or more postoperative complications. Complications were defined and graded according to the Clavien-Dindo classification system and the "Expert Consensus on Postoperative Complications Registration for Gastrointestinal Tumor Surgery (2018 Edition)". Major complications were defined as Clavien-Dindo grade III or higher.

次要结局

  • Length of Hospital Stay(Up to 60 days post-surgery (data collected at discharge))
  • Intensive Care Unit (ICU) Admission Rate(Up to 30 days post-surgery)
  • Unplanned 30-Day Readmission Rate(Within 30 days of discharge)
  • Unplanned 60-Day Readmission Rate(Within 60 days of discharge)

研究者

发起方
Third central hospital of Tianjin affiliated Nankai university
申办方类型
Network
责任方
Principal Investigator
主要研究者

Dongping Xu

Principal investigator

Third central hospital of Tianjin affiliated Nankai university

研究点 (1)

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