Registry of the Spanish Society of Thoracic Surgery (ReSECT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Rate of perioperative mortality
研究概览
简要总结
ReSECT is a project promoted by the Spanish Society of Thoracic Surgery with the aim not only to become an indefinite, dynamic and inclusive registry, but also to establish a common structural framework for the development of future multicentre projects in the field of thoracic surgery in Spain.
The goal of this nationwide prospective observational registry is:
- To develop and validate forecasting tools based on powerful computational methods with the goal of assisting in decision-making and improving quality of care.
- To evaluate the progressive implementation of certain surgical techniques that are on the rise, new technologies and future health programs.
- To be aware of our results as specialty and professionals and to serve as a permanent benchmarking instrument in thoracic surgery.
The first part of ReSECT, based on a personal registry design, will contemplate any thoracic surgical procedure performed by thoracic surgeons and residents in thoracic surgery in our country. Additionally, the Spanish thoracic surgery departments that voluntarily accept to collectively participate will contribute to specific surgical processes focused on certain procedures with specific objectives to be progressively implemented.
The first and only surgical process implemented since the start of the ReSECT project will focus on patients to undergo anatomical lung resection with special interest in those cases whose reason for intervention was lung cancer.
The main questions to answer in case of that first surgical process include:
- What is the performance of current predictive models for perioperative and oncological outcomes in our country?
- How could we modify previous predictive models to improve their performance?
- What is the implementation of current guideline recommendations in our country and across institutions?
- What is the potential impact of deviations from current recommendations?
- What is my performance compared to the rest of the thoracic surgical departments in my country in terms of perioperative and oncological outcomes?
ReSECT does not consider prespecified comparison groups of patients.
详细描述
ReSECT is intended for SECT members including thoracic surgery specialists and residents with professional practice in Spain, as well as thoracic surgery departments in our country.
Participation in ReSECT may be at the individual level (personal surgical registry) or by department (ReSECT surgical processes). Those thoracic surgery departments interested in participating in a surgical process implemented in ReSECT must be represented by a single responsible hospital user.
ReSECT will be a clinical registry based on surgical procedures. The retrospective and prospective nature of the personal surgical record will be determined by the user's ability to include records of patients who underwent surgery prior to the approval of the current project. However, the "retrospective patients" to be included must belong to the centre associated with each user at the time of registering on the platform. In other words, it will not be feasible to include patients operated on in other institutions where the professional had previously worked.
The first ReSECT surgical process about anatomical lung resections and the successive processes that are to be created in the future, will only contemplate patients operated on prospectively with respect to the date of approval of each surgical process.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients who could reject to participate in this study.
结局指标
主要结局
Rate of perioperative mortality
时间窗: From surgery date to hospital discharge day or within ninety days.
Mortality during hospitalization or that occurred within thirty and ninety days after surgery.
Rate and severity of perioperative morbidity
时间窗: From surgery date to hospital discharge day or within thirty days.
Complications occurred during hospitalization will be classified into 3 groups: cardiovascular, respiratory and other type of complications. Each of these groups of complications will be classified based on the most severe specific complication according to the Clavien-Dindo classification (grade I, II, IIIa, IIIb, IVa, IVb, V). Specific respiratory complications: initial ventilator support \> 48h, re-intubation, ARDS, pneumonia, atelectasis, air leak \> 5 days, pulmonary embolism, acute respiratory failure, phrenic palsy, pulmonary infarction, pneumothorax, pleural effusion, subcutaneous emphysema, chylothorax, bronchopleural fistula, others. Specific cardiovascular complications: blood transfusion, arrhythmia, myocardial infarction, heart failure, cerebrovascular accident, deep vein thrombosis, others. Other type of complications: no-respiratory sepsis, wound infection, renal failure, delirium, others.
Overall survival
时间窗: Five-year follow-up after surgery
Overall survival after anatomical resection for lung cancer. The outcome will include exitus for any reason.
Disease specific survival
时间窗: Five-year follow-up after surgery
Disease free survival after anatomical resection for lung cancer. The outcome will include exitus for lung cancer progesssion.
Recurrence free survival
时间窗: Five-year follow-up after surgery.
Recurrence free survival after anatomical resection for lung cancer. The outcome will include recurrence of lung cancer.
次要结局
- Unplanned Intensive Care(From day of surgery to day of hospital discharge or within 30 days)
- Rate of patients with functional status classified as independent, partially independent of totally dependent(The day of hospital discharge or within 30 days after surgery.)
- Rate of occult pN2 disease(During the surgery)
- Rate of hospital readmission(From hospital discharge day to thirty days afterwards.)
- Rate of patients that required surgical reintervention(From surgery date to hospital discharge day and from hospital readmission date to hospital discharge day or within 30 days)
- Rate of patients with invasive mediastinal staging(From three months before surgery to surgical intervention date)
- Rate of complete resection for lung cancer(During the surgery)
- Mean postoperative stay(From day of surgery to day of hospital discharge or within 3 months.)
- Diagnosis and severity of complications during hospital readmission.(From hospital readmission date to hospital discharge day or within 30 days)
- Distribution of patients according to type of lymphadenectomy(During the surgery)