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临床试验/NCT06938139
NCT06938139进行中(未招募)不适用

Defining Benchmarks for Gastric Cancer Patients Underwent Minimal Invasive Gastrectomy: A Multicentre Analysis

Fujian Medical University1 个研究点 分布在 1 个国家目标入组 90,000 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
90,000
试验地点
1
主要终点
Benchmark values of overall complication

研究概览

简要总结

The Benchmark-MISGC study was a large-scale retrospective observational study launched by the China Gastric Cancer Surgical Union, aiming to establish the benchmarks of the short- and long-term outcomes for gastric cancer patients who underwent minimal invasive gastrectomy.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with postoperative histologically confirmed gastric adenocarcinoma at stages T1-4a, N0/+, M0;
  • underwent robotic or laparoscopic gastrectomies with curative intent

排除标准

  • ASA class > 3;
  • remnant gastric cancer;
  • concurrent/previous malignant disease;
  • Distant metastasis;
  • Palliative resection;
  • Abodominal exploration.

结局指标

主要结局

Benchmark values of overall complication

时间窗: 30 days

Median values of continuous variables and the proportions of categorical variables were calculated per participating centre. Benchmark values, indicating 'best achievable' results for each outcome indicator, were set at the 25th percentile for positive parameters (for example lymph node yield) or the 75th percentile for negative parameters (for example complications) of the centers' median values. Postoperative complications were evaluated within 30 days following surgery. These postoperative complications include gastrointestinal-related complications, incision-related complications, respiratory complications, cardiovascular and cerebrovascular complications, urinary system complications, infection complications, embolism complications, and other complications. The grading of postoperative complications adopts the Clavien-Dindo classification.

次要结局

  • Benchmark values of textbook Outcome(30 days)
  • Benchmark values of Overall survival (OS)(1-year, 2-year and 3-year)
  • Benchmark values of Disease-specific survival (DSS)(1-year, 2-year, and 3-year)
  • benchmark value of the number of harvest lymph nodes(1 month)
  • Benchmark values of Mortality rates(30 days)
  • Benchmark values of the incidence of intraoperative complications(1 days)
  • Benchmark values of Intraoperative blood loss(1 day)
  • Benchmark values of operation time(1 day)

研究者

发起方
Fujian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang-Ming Huang, Prof.

Director of Gastric Surgery department

Fujian Medical University

研究点 (1)

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