The Impact of Frailty on the Postoperative Outcomes of Gastric Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- 90-day mortality
研究概览
简要总结
Background. Gastric cancer is an important health care problem even though treatment advances, and it is diagnosed mainly in elderly. Surgery is the main treatment for gastric cancer and is associated with a high rate of postoperative complications and mortality, even higher in older patients. Chronological age seems not to be the main factor influencing the worse outcome of older patients, comorbidities and frailty have also been taken into account recently.
Methods. Participation in the study will be offered to all centers that are currently part of the Spanish EURECCA (EUropean REgistry of Cancer CAre) Esophagogastric Cancer Registry. The impact of the frailty on different outcome variables will be evaluated. The main outcome variable will be 90-day mortality after the intervention. Health-Related Quality of Life (HRQoL) will also be evaluated.
Objective. The objective of the study is to value the impact of frailty on gastric cancer surgery outcomes therein the Spanish EURECCA Esophagogastric Cancer Registry.
详细描述
Introduction
Gastric cancer is the fifth most frequent cancer and the third cause of death due to cancer. The increase in life expectancy cause it to be diagnosed more and more in elderly people, with an average age at diagnosis of 68 years in the West.
Surgery is the main treatment for gastric cancer and is associated with a high rate of postoperative complications and mortality, which is even higher in elderly patients (data from the ACS-NSQIP between 2007 and 2013: 30-day severe morbidity from 16.3% in 80 years and 30-day mortality from 1.2% in 80 years).
Generally, advanced chronological age is considered a negative prognostic factor for complications and hospital stay in major surgery. Age per se, however, seems to be responsible only in part for the increased risk of postoperative complications.
Greater risks seem to be associated with other factors such as comorbidities, so, in the preoperative evaluation, variables such as the Charlson comorbidity index have been introduced. Another variable that has emerged recently for the estimation of perioperative risk is frailty, which is defined as "a medical syndrome with multiple causes and contributors that is characterized by a decrease in strength, endurance and physiological capacity, which increases the risk of the vulnerability of the individual and/or death". Surgery is a major stress factor that can disrupt physiological homeostasis; therefore, frailty has a clinical significance when considering surgery in elderly patients.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 70 years patients diagnosed with gastric cancer candidates for radical resection
排除标准
- •metastatic patients
- •patients candidates for palliative treatment
- •patients without a signed informed consent
结局指标
主要结局
90-day mortality
时间窗: 90 days after surgery
Mortality at 90 days after surgery
次要结局
- Complication Comprehensive Index(30 days after surgery)
- Readmission(30 days after discharge)
- Health-related Quality of life before the intervention (EORTC-QLQ-STO22)(2 weeks before surgery)
- Health-related Quality of life at 12 months (EORTC-QLQ-STO22)(12 months after surgery)
- Health-related Quality of life before the intervention (EORTC-QLQ-C30)(2 weeks before surgery)
- Severe complications(30 days after surgery)
- Failure to rescue(30 days after surgery)
- Hospital stay(30 days after surgery)
- Patient discharge facility(30 days after surgery)
- 12-month mortality(12 months after surgery)
- Health-related Quality of life at 12 months (EORTC-QLQ-C30)(12 months after surgery)
研究者
Manuel Ramón Pera Román
Professor of Surgery, Head of Section of Gastrointestinal Surgery
Parc de Salut Mar