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临床试验/NCT05280665
NCT05280665已完成不适用

The Impact of Specialization on Clinical Outcomes in Gastric Cancer Surgery

Karadeniz Technical University1 个研究点 分布在 1 个国家目标入组 537 人开始时间: 2022年2月14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
537
试验地点
1
主要终点
30-day mortality

研究概览

简要总结

Specialization is having competent and effective knowledge on a subject, and the tendency towards specialization is increasing due to the fact that it increases the success in the follow-up and treatment process of diseases. It has been observed that specialization in cancer surgery provides significant improvement in clinical outcomes in recent years. In this study, the effect of specialization in gastric cancer surgery on clinical outcomes is being investigated.

详细描述

Specialization is having sufficient and effective knowledge on a subject. Today, in the medical world, specialization is defined as having competent knowledge on a disease, and in recent years, the benefit of specialization has begun to be emphasized. Initially, it was defined as a branching and over the years, internal and surgical departments were divided into sub-areas. In surgical sciences, these fields are determined as traumatology, breast-endocrine surgery and gastrointestinal system surgery. This branching has brought a different perspective and approach to diseases and has made it possible to be more effective in the management of diseases. In recent years, a specialization approach on diseases and organ systems has developed within these branches. In surgery, surgeons specialized on many organs such as pancreatic surgery, colorectal surgery, gastric surgery, breast surgery, ovarian surgery have increased the efficiency in the management of diseases and the survival and disease-free survival rates of the patients have increased, and the postoperative morbidity and mortality rates have decreased.

Gastric cancer is one of the most common malignant cancers. It is the fifth most common cause of cancer-related death worldwide. Despite advances in diagnosis and treatment methods, patients may still be diagnosed late, and patients still have a poor prognosis due to the biology of gastric cancer. Even in properly treated patients, five-year survival rates are around 20-30%. With the development of surgical techniques and disease management, clinical outcomes of the disease have improved and mortality has been reduced. In the studies, the definition of gastric surgeon was created and it was determined that the mortality decreased proportionally with the increase in the patient volume of the surgeon. In gastric cancer surgery, there are mostly studies on the number of surgeon patients and the number of hospital patients. Post-hoc analysis of hospital volume on patients included in the CRITICS study showed a 13.1% increase in survival in high-volume hospitals compared to low-volume hospitals. The number of annual resections ≥21 was determined as the definition of high-volume hospital. In addition, it was determined that there was a decrease in mortality as the number of annual cases increased in high-volume hospitals. In another study, it was seen that there was an improvement in the mortality of medium and high volume hospitals compared to low volume hospitals. The majority of studies in gastric cancer surgery have focused on hospital volume and surgeon volume. There are no data on the specialization of the surgeon other than a study based in Japan.

In this study, it was aimed to evaluate the effect of specialization in gastric cancer surgery on short- and long-term clinical outcomes.

研究设计

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

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

  • cStage I/II/III gastric cancer
  • Histologically proven gastric adenocarcinoma
  • Underwent surgery with curative intent

排除标准

  • Under 18 years old
  • Patients with non-adenocarcinoma diagnosis
  • Emergency surgeries
  • The need for a thoracic approach
  • Patients with a history of non-gastric cancer

结局指标

主要结局

30-day mortality

时间窗: 30 days after the operation (postoperative hospital stay ≤ 30 days) or operation to first discharge from hospital (postoperative hospital stay > 30 days)

Death from any cause within 30 days after surgery or at any time if not discharged from hospital

次要结局

  • Postoperative complication rate(Within 30 days after the operation)
  • Readmission(Within 30 days after the operation)
  • Postoperative major complication rate(Within 30 days after the operation)
  • 90-day mortality(90 days after the operation (postoperative hospital stay ≤ 90 days) or operation to first discharge from hospital (postoperative hospital stay > 90 days))
  • 3-year overall survival(3 years after surgery)
  • 3-year recurrence-free survival(3 years after surgery)
  • Hospital stay(From the date of surgery until the date of hospital discharge, assessed up to 90 days after the operation)

研究者

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

Ali GUNER

Professor, MD

Karadeniz Technical University

研究点 (1)

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