Registry of the Spanish Society of Thoracic Surgery

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Rate of perioperative mortality — 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 — 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 — 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 — 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 — Five-year follow-up after surgery.
  Recurrence free survival after anatomical resection for lung cancer. The outcome will include recurrence of lung cancer.

Trial sites (1)

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