About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Personal registry: patients undergoing any type of surgical intervention.
Registry of surgical processes by departments: patients undergoing an anatomical pulmonary resection as the first process to be implemented at the time ReSECT is to be established.
Disqualifiers
Patients who could reject to participate in this study.
Trial population
All the patients that could requiere an intervention in the Spanish Thoracic Surgery Departments
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Rate of perioperative mortality
Mortality during hospitalization or that occurred within thirty and ninety days after surgery.
Rate and severity of perioperative morbidity
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
Overall survival after anatomical resection for lung cancer. The outcome will include exitus for any reason.
Disease specific survival
Disease free survival after anatomical resection for lung cancer. The outcome will include exitus for lung cancer progesssion.
Secondary outcomes
Rate of hospital readmission
Readmissions within thirty days of discharge from hospital for reasons related to the surgical procedure.
Diagnosis and severity of complications during hospital readmission.
Primary reason for readmission and severity of complications from readmission date to hospital discharge day
Unplanned Intensive Care
Rate of patients who required unplanned intensive care unit admission
Rate of patients that required surgical reintervention
Surgical reinterventions will be considered when related to complications secondary to the main surgical procedure. This rate will be calculated: number of patients that required reintervention during main hospitalization of after readmission / total number of patients.
Sponsors and contacts
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