Risk Factors for Postoperative Outcomes and Complications in Patients With Large Intrathoracic Tumors: A Multicenter Analysis
Risk Factors for Outcomes and Postoperative Complications in Patients with Large Intrathoracic Neoplasms (GIANTOR) What is the purpose of this study? The main goal of this study is to evaluate the results of surgery for removing very large tumors inside the chest. While common lung cancers are well-studied, other types of chest tumors (like solitary fibrous tumors or nerve-related tumors) can grow slowly and reach a massive size (over 5 cm) before they are found. Because these cases are rare, there is little data on the best way to operate on them. Researchers want to identify the risks and complications associated with these surgeries to improve patient care.
Why is this study important? Operating on large chest tumors is technically difficult because they often press against or grow into nearby vital organs. Currently, doctors mostly rely on reports of single cases rather than large groups of patients. This study will look at a large multicenter group to provide more reliable information on surgical techniques (such as open surgery vs. minimally invasive) and long-term recovery.
Who can participate in this study? The study includes patients who meet the following criteria:Adults aged 18 years or older.Patients with intrathoracic tumors measuring 5 cm or larger.Tumors that can be either benign (non-cancerous) or malignant (cancerous).Patients who underwent surgery with the intent to completely remove the tumor.The study excludes patients with common non-small cell lung cancer (NSCLC), thymomas, or sarcomas of the chest wall.
How is the study designed? This is a multicenter, retrospective and prospective cohort study. It is led by the IRCCS Azienda Ospedaliero-Universitaria di Bologna and involves six other major thoracic surgery centers in Italy (Rome, Padua, Turin, Pisa, and Milan).Researchers will review medical records of approximately 400 patients who had surgery between January 2005 and December 2024. Data will be collected on:Surgical complications during and after the operation.The type of surgical access used.Patient survival and disease recurrence.
What are the expected outcomes? Researchers hope to:Determine the rate of complications and deaths related to the surgery.Find specific risk factors (like patient health or tumor size) that lead to more complications.Compare different surgical methods to see which works best for large tumors.Measure long-term survival and how long patients stay free of disease after surgery.The results will be shared through scientific journals and international conferences to help surgeons worldwide manage these complex cases more safely.
研究概览
地位
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Pietro Bertoglio, MD
- 电话号码:0516478362
- 邮箱:pietro.bertoglio@aosp.bo.it
学习地点
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Bologna
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Bologna、Bologna、意大利、40138
- 招聘中
- IRCSS Azienda Ospedaliero-Universitaria di Bologna
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接触:
- Pietro Bertoglio, MD
- 电话号码:0516478362
- 邮箱:pietro.bertoglio@aosp.bo.it
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study population consists of patients who underwent surgery for large intrathoracic tumors at the participating centers between January 2005 and December 2024. Subjects will be identified through a review of medical records, surgical registries, and outpatient documentation available at the participating facilities, and enrollment will take place during scheduled outpatient follow-up visits or via telephone contact made during postoperative follow-up, in accordance with the standard care pathway. In both cases, patient selection will be conducted in accordance with the inclusion and exclusion criteria established in the protocol, following verification of the available clinical documentation.
描述
Inclusion Criteria:
- Age ≥ 18 years
- Intrathoracic tumors ≥ 5 cm in size
- Tumors with either benign or malignant histology
- Tumors treated surgically with the aim of complete resection
Exclusion Criteria:
- NSCLC
- Thymomas
- Wall sarcomas
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:RETROSPECTIVE
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Intraoperative complication rate, postoperative complication rate
大体时间:baseline
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baseline
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Relationship between the development of complications and the presence of pre- or intraoperative risk factors
大体时间:baseline
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baseline
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Perioperative mortality rate
大体时间:baseline
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baseline
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Rate of surgical approach utilization
大体时间:baseline
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baseline
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Overall Survival and Disease-Free Survival
大体时间:baseline
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baseline
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association of surgical approach utilization with postoperative complications
大体时间:baseline
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baseline
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- GIANTOR
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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