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临床试验/NCT03958032
NCT03958032已完成不适用

Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer

Karadeniz Technical University1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2016年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
185
试验地点
1
主要终点
Postoperative complications

研究概览

简要总结

We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer

详细描述

Among gastrointestinal disease, gastric cancer is a malignancy which is diagnosed predominantly in advanced stages, mostly accompanied with malnutrition when diagnosed, has aggressive behavior with poor oncological outcomes. The only option for curative treatment is surgical resection in this malignancy; however, the surgical procedure itself causes high morbidity and mortality rates. Therefore, physicians combine various treatment modalities and risk assessment to decrease complication and mortality rates.

Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. For the diagnosis of sarcopenia, using the presence of both low muscle mass and decreased muscle function (strength or performance) is recommended. Previous studies showed that colorectal or pancreatic cancer accompanied with sarcopenia has adverse effects on not only for short term and also for long term outcomes. The majority of studies regarding gastric cancer was published from Eastern countries owing to their high incidence. There are few studies from western countries which are mostly retrospective and does not meet the diagnostic criteria of sarcopenia. In the western population, there is no high-quality evidence so far regarding the impact of sarcopenia on early outcomes of gastric cancer surgical treatment.

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

入选标准

  • Patients undergoing gastric surgery for gastric cancer
  • Histologically proven gastric adenocarcinoma
  • Patients over 18 years
  • Patients who agreed to participate in the study

排除标准

  • patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)
  • patients received palliative surgery without gastric resection (bypass procedures)
  • patients required thoracotomy/thoracoscopy

结局指标

主要结局

Postoperative complications

时间窗: within 30 days after surgery

complications graded by Clavien-Dindo Complication Classification System

次要结局

  • Length of hospital stay(up to 90 days)
  • Readmission rate(within 30 days after surgery)
  • Mortality(within 30 days after surgery)
  • Psoas muscle mass volume(one day before surgery)
  • Incidence of sarcopenia(one day before surgery)
  • Muscle mass volume(one day before surgery)
  • Muscle strength(one day before surgery)
  • Physical performance(one day before surgery)
  • Major complication(within 30 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali GUNER

Associate Professor

Karadeniz Technical University

研究点 (1)

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