Registry of the Spanish Society of Thoracic Surgery (ReSECT)
Conditions: Pulmonary Surgical Procedures, Thoracic Surgery, Video-assisted, Robotic Surgical Procedures, Thoracotomy, Lung Neoplasm
Sponsor: Sociedad Española de Cirugía Torácica

 
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SUMMARY PROTOCOL 
REGISTRY OF THE SPANISH SOCIETY OF  
THORACIC SURGERY 
 
 
 
 
 
October 2022 

 
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Content 
1. 
Justification ................................................................................................................................... 3 
2. 
Hypothesis..................................................................................................................................... 7 
3. 
Objectives ..................................................................................................................................... 7 
A. 
General Objectives........................................................................................................................... 7 
B. 
Specific Objectives ........................................................................................................................... 7 
4. 
Participants ................................................................................................................................... 8 
5. 
Design ........................................................................................................................................... 8 
A. 
Personal surgical registry. ............................................................................................................... 9 
B. 
Registry of surgical processes by department. ................................................................................ 9 
C. 
Relationship between forms .......................................................................................................... 10 
6. 
Patients ....................................................................................................................................... 11 
A. 
Inclusion criteria ............................................................................................................................ 11 
B. 
Sample size .................................................................................................................................... 12 
7. 
Statistical analysis ....................................................................................................................... 12 
8. 
Audit ........................................................................................................................................... 14 
A. 
In data collection. .......................................................................................................................... 14 
B. 
Internal audit systems ................................................................................................................... 14 
9. 
Limitations .................................................................................................................................. 14 
10. 
Regulation ............................................................................................................................... 15 
11. 
Patient privacy ........................................................................................................................ 16 
12. 
Ethics committee approval ...................................................................................................... 17 
13. 
Information document for the participant .............................................................................. 18 
 

 
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1.  Justification 
The Spanish Society of Thoracic Surgery (SECT) is a scientific society founded in 2007 and constituted for 
an indefinite period whose objective is to contribute to the progress of thoracic surgery in all its aspects, 
promoting training, development, and professional improvement of thoracic surgeons, seeking the best 
quality in patient care, and promoting teaching and research (1). 
One of the objectives of the SECT since its inception has been to promote research by carrying out multi-
center projects to foster both experimental and basic research, as well as clinical research in the most 
rigorous way possible.  
The Registry of the Spanish Society of Thoracic Surgery is a project promoted by the Board of Directors of 
our society whose initial design began in January 2022. ReSECT project aims not only to become an 
indefinite, dynamic and inclusive registry of the Spanish thoracic surgery, but also to establish a common 
structural framework for the development of multicenter projects. Despite this common structural basis, the 
incorporation of such future multicenter studies will be subject to the corresponding approval by an 
accredited clinical research committee. 
The data model of the current ReSECT project derives partially from the model used by the Spanish Group 
of Video-Assisted Thoracic Surgery (GEVATS), which was established as a SECT working group in 2015. 
It is a multicenter group made up of 33 national thoracic surgery services whose main objective was to 
analyse the impact of the surgical approach on postoperative morbidity and mortality after anatomical 
pulmonary resection, and oncological prognosis after this technique in the subgroup of patients operated on 
for lung cancer (2).  
Based on figures published by the Spanish Ministry of Health on the number of major lung resections 
performed by the national thoracic surgery services, the GEVATS sample (3533 patients in 15 months) 
represented approximately 53% of the major lung resections performed in Spain during the recruitment 
period. This type of surgical procedure accounts for most major surgical procedures performed on the 
respiratory system. 
Despite this remarkable representativeness, one of the main limitations of the GEVATS has to do with the 
limited time frame in which it was developed and, consequently, its inability to carry out continuous quality 
control through adequate analysis techniques. On the other hand, the limited number of patients per surgical 
department (median 100 patients and p25-p75 68-136 patients) did not allow robust conclusions to be drawn 
on performance for inter-institutional benchmarking purposes. We believe that the current ReSECT project 
can overcome both limitations and represent a turning point in national thoracic surgery research. 
 

 
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Annual number of major pulmonary resections performed by Thoracic Surgery Services in Spain  
(Statistical portal. Management intelligence area of the Ministry of Health) 
 
 
Annual relationship of the number of major surgical procedures on the respiratory system.  
(Statistical portal. Management intelligence area of the Ministry of Health) 
 
Thoracic surgery represents a small proportion of surgical procedures with hospital admission performed in 
our country. In fact, according to data from the Ministry of Health itself, our volume with some 25,000 
procedures/year represents the second lowest for surgical services, surpassing only the specialty of 
dermatology (3). 
 
Volume of inpatient surgical procedures by specialties 
The fact that it represents a "small" specialty and that almost all thoracic surgical procedures in the adult 
population in our country are the responsibility of the thoracic surgeon, unlike what happens in other 

 
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countries where general, cardiothoracic or cardiovascular surgeons commonly participate in such 
procedures, places this project in a privileged position to be able to carry out comparative studies with data 
obtained from administrative records, as they recently did in France from their Epithor registry (4). 
 
 
Over the last two decades, many predictive models have been developed, mainly in terms of perioperative 
prognosis, in the field of thoracic surgery. However, the number of works that have tried to validate these 
models and their updating over the years is scarce. GEVATS was able to develop a predictive model of 
postoperative morbidity and mortality, internally validated by resampling techniques, after anatomical lung 
resection, as well as to perform external validation of the main European models, Eurolung 1 and 2 (5)(6).  
Despite the work carried out by GEVATS, its cohort, whose recruitment ended more than 4 years ago, will 
not be adequate to respond in a contemporary way to the value of future regression, classification, and 
survival models. The significant increase in the availability of data on an ongoing basis will enable ReSECT 
to develop and validate forecasting tools based on much more powerful computational methods, and with 
fewer assumptions than traditional statistical methods, with the goal of assisting in decision-making and 
improving our quality of care.  
Finally, ReSECT stands as a dynamic registry that is continuously updated, which will allow us to evaluate 
the progressive implementation of certain surgical techniques that are on the rise (segmentectomies...), new 
technologies (robotic surgery platforms...) and future health programs (early detection of lung cancer), as 
well as the results derived from them for our specialty, professionals and population served. 
 
 

 
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Bibliography 
1.  
Sociedad Española de Cirugía Torácica. Estatutos de la Sociedad Española de Cirugía Torácica 
[Internet]. [cited 2022 Jun 9]. Available from: 
https://www.sect.es/images/Estatutos_SECT_2022.pdf 
2.  
Embun R, Royo-Crespo I, Recuero Díaz JL, Bolufer S, Call S, Congregado M, et al. Spanish Video-
Assisted Thoracic Surgery Group: Method, Auditing, and Initial Results From a National Prospective 
Cohort of Patients Receiving Anatomical Lung Resections. Arch Bronconeumol [Internet]. 2020 Nov 
[cited 2022 Jun 9];56(11):718–24. Available from: https://pubmed.ncbi.nlm.nih.gov/35579917/ 
3.  
Ministerio de Sanidad. Consulta Interactiva del SNS [Internet]. [cited 2022 Jun 9]. Available from: 
https://pestadistico.inteligenciadegestion.mscbs.es/publicoSNS/C/siae/siae/hospitales/actividad-
asistencial/actividad-quirurgica 
4.  
Bernard A, Falcoz PE, Thomas PA, Rivera C, Brouchet L, Baste JM, et al. Comparison of Epithor 
clinical national database and medico-administrative database to identify the influence of case-mix 
on the estimation of hospital outliers. PLoS One. 2019;14(7):1–13.  
5.  
Gómez de Antonio D, Crowley Carrasco S, Romero Román A, Royuela A, Sánchez Calle Á, Obiols 
Fornell C, et al. Surgical Risk Following Anatomic Lung Resection in Thoracic Surgery: A Prediction 
Model Derived from a Spanish Multicenter Database. Arch Bronconeumol. 2022;58:398–405.  
6.  
Gómez de Antonio D, Crowley Carrasco S, Romero Román A, Royuela A, Gil Barturen M, Obiols 
C, et al. External validation of the European Society of Thoracic Surgeons morbidity and mortality 
risk models. Eur J Cardiothorac Surg. 2022;62(3):ezac.  
 
 
 
 

 
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2.  Hypothesis 
The creation of a permanent, inclusive, and dynamic clinical registry promoted by the Spanish Society of 
Thoracic Surgery will be a turning point in clinical research and healthcare activity of the Spanish thoracic 
surgery, by being better aware of our clinical practice, our results and our expectations as professionals, 
institutions, and specialty. 
3.  Objectives 
A.  General Objectives 
1. Promote a better quality of care in Spanish thoracic surgery. 
2. Promote more efficient research through a common platform for the development of future multicenter 
studies of Spanish thoracic surgery. 
3. Collaborate with the professional activity of SECT members by creating a surgical personal registry. 
4. Collaborate with other national and international registries of our specialty. 
B.  Specific Objectives 
1. To know the evolution of the main epidemiological and clinical characteristics of patients operated on for 
thoracic pathology in our country. 
2. To evaluate the progressive implementation of new surgical techniques, health technologies or health 
programs that affect our specialty. 
3. To validate perioperative risk models and international oncology prognostic classifications in our 
environment. 
4. To develop and validate our own perioperative and oncological predictive models (overall survival, 
disease-specific survival, and recurrence-free survival) that allow us to establish quality standards for 
benchmarking purposes among professionals and institutions in our country. 
5. Evaluate and quantify the existence of random effects between institutions on the main perioperative 
prognostic parameters. 
6. To know adherence globally and by institutions to the main clinical practice recommendations in our 
specialty. 

 
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4.  Participants 
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) and 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. These users 
will be responsible for: 
• To ensure the complete recruitment of patients from her/his institution for those ReSECT surgical 
processes in which they have expressed their intention to participate voluntarily. 
• To communicate the registrations and cancellations of users of his/her institution in due time. 
• To export the data of her/his institution and share it with its users. 
The complete recruitment of those surgical processes in which each center participates will be a priority. 
The ReSECT executive committee will recommend to those centers with a constant low level of participation 
in a certain surgical process, the appointment of a new user as hospital manager, and ultimately the 
temporary exclusion of his/her center for a period of two years for the surgical procedure in question. 
5.  Design 
ReSECT will be a clinical registry based on surgical procedures. The retrospective/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 center 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 of 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.  

 
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A.  Personal surgical registry. 
Due to the personal nature of this record, a certain surgical procedure in a specific patient may have up to 
five personal entry records depending on the professional's participation in the procedure (principal surgeon, 
first assistant, second assistant, third assistant, without participation in the process). 
The personal record will be private for the user who creates it, that is, none of the other users will be able to 
view or modify the personal record data of another colleague. 
When a professional leaves a certain institution, the data center, or the scientific director of ReSECT will 
transfer the pseudonymized data corresponding to their personal records entered during their professional 
activity in that institution. However, those data will continue to be hosted on the platform on behalf of the 
institution of origin and under the same conditions that regulate the personal records belonging to the users 
of each center. 
B.  Registry of surgical processes by department.  
When ReSECT is established, all thoracic surgery departments in Spain will be invited to participate 
voluntarily in the first ReSECT surgical process of anatomical lung resections. As different surgical 
processes are implemented, the corresponding invitations will be made, in such a way that a certain 
department will participate only in those surgical processes that are of interest to it. 
Every patient included in a ReSECT surgical process must have been previously included as a personal 
surgical record by one of the users of each department, whether or not they have participated in the 
intervention. Thus, it will be the internal decision of each department to determine which user or users must 
complete the different forms of the patients included in a surgical process. However, for a better quality in 
data completion, it is recommended that at least the surgical intervention form be completed by one of the 
surgeons who participated in the procedure. Unlike the personal record, the data within a certain surgical 
process is visible and editable by all users of each center.  
 
Relationship between Personal Registry and Anatomical Pulmonary Resection Process 

 
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The previous figure describes unlikely situations in which: A) All professionals who have participated in an 
intervention add a personal record, but the procedure is not included in the anatomical lung resection 
process because the service did not want to participate; B) All professionals who have participated in an 
intervention add a personal record, but the service has decided that it is a specific professional, who in this 
case has not participated in the surgical procedure, who includes the data in the process of anatomical  lung 
resections. 
 
 Relationship between Personal Registry and Anatomical Pulmonary Resection Process (most likely situations) 
 
The figure above represents the most probable situations of the relationship between the personal surgical 
record and the anatomical lung resection process: A) Two of the professionals who have participated in the 
intervention add a personal record, and one of them includes the surgical procedure within the process of 
anatomical lung resections; B) None of the professionals who have participated in the intervention add a 
personal record, but the department has decided that it be a certain professional, who in this case has not 
participated in the surgical procedure, who includes the data in the anatomical lung resection process. 
C.  Relationship between forms 
The ReSECT database at the time it is established will be made up of seven forms: clinical identification 
data (7 variables), personal surgical record (21 variables in a single form) and anatomical lung resection 
process (138 variables distributed in 5 forms). The nature and relationship between forms will be defined 
by: 
1.  Clinical identification data form: mandatory for all patients in the registry as a prior step to 
completing a personal registry. 
2.  Personal surgical record form: at least one personal record is mandatory as a form of access to 
the different surgical processes. Each personal record will give rise to a procedure identifier that 
will be a self-calculated composite field that will include the following variables: surgery date – main 
procedure – procedure subtype (for example: 2022-06-01_Pulmonary_Pneumonectomy). The 

 
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variables contained in the personal registration form may be fully completed at the time of hospital 
discharge. 
3.  Group of anatomical pulmonary resection process forms: enabled for a specific patient if there is a 
personal record associated with that patient containing a compatible procedure identifier (yyyy-
mm-dd _Pulmonary _ Segmentectomy / lobectomy / bilobectomy / pneumonectomy). The 
activation of this and future processes is enabled from the clinical data form once a personal record 
compatible with the surgical process in question has been included.  
Although a certain surgical procedure had been the subject of several personal records, that 
procedure may only be the subject of a single entry in the process of anatomical lung resections. 
The relationship between the forms of this process is: 
a.  Postoperative form: enabled if the patient did not die during the surgery. 
b.  Short-term follow-up form (hospital readmission): enabled if the reason for discharge was 
other than death. 
c.  Long-term follow-up form: enabled if the patient did not die during the first 90 
postoperative days and the reason for surgery was a primary malignant lung tumor. Long-
term follow-up is recommended for a period of approximately 5 years. 
The data will be collected directly through the web platform designed for this project and managed by the 
digital health company Persei Vivarium. This platform will have an adaptive design for correct viewing and 
usability on mobile devices, facilitating the completion of data in real time. 
In addition, for the same purpose, the information collected in each registration form may be exported to a 
pseudonymized .pdf file that may be imported as an attachment to the electronic medical record of each 
patient or simply copy and paste the content of said document in the evolutionary or corresponding clinical 
report. 
6.  Patients 
A.  Inclusion criteria 
The inclusion criteria will depend on the section of the registry to be considered. 
• 
Personal record: patients undergoing any type of surgical intervention on the thorax or its border 
territories. 
• 
Registry of ReSECT Surgical Processes by services: patients undergoing an anatomical 
pulmonary resection as the first process to be implemented at the time ReSECT was established. 
 

 
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B. Sample size 
Taking into account the history of the Spanish Video-assisted Thoracic Surgery Group (3,533 procedures in 
15 months of recruitment), the more inclusive nature of the current project, and the number of major lung 
resections in our country, according to figures from the Ministry of Health (5,000 cases per year ), our 
estimate is that the first surgical process of ReSECT, based on anatomical lung resections, will involve a 
recruitment of at least 3000 surgical procedures per year. 
Although the current project represents the design of a patient registry and not a specific project based on 
that registry, we have considered of special interest the estimation of the sample size with a view to the 
development of future predictive models based on one of the perioperative outcomes of greatest interest 
with a lower incidence (in-hospital death 2%), and therefore maximizing the statistical power with respect to 
other possible outcomes. 
For this calculation, the following parameters were used: proportion of patients who died before discharge 
from the GEVATS (0.0158), shrinkage factor to control model overfitting (0.9) and Cox Snell Pseudo R2 
value (0.032) based on the following model within GEVATS cohort: hospital death ~ age + sex + fev1ppo + 
dlcoppo + surgical approach + type of pulmonary resection. From these parameters, the necessary sample 
size was determined based on the number of independent variables to include: 5 variables (1353 patients), 
6 variables (1624 patients), 7 variables. (1894 patients), 8 variables (2165 patients), 9 variables (2435 
patients), 10 variables (2706 patients). 
The calculation was made using the DescTools and pmsampsize libraries for R 4.2.0 software under the R 
Studio 2022.02.3+492 development environment. 
7.  Statistical analysis 
All the specific studies that are developed from this registry, with specific objectives in line with those 
previously defined for this project, must have the collaboration, by internal regulations, of a professional in 
data analysis. That professional must sign as such and appear as co-author of the published work or in the 
acknowledgments section together with the institution to which he/she belongs or other information that may 
facilitate his/her professional affiliation.  
The periodic scientific reports will include a descriptive analysis globally and disaggregated by department 
based on the main variables of the registry. Despite the meticulous design of the web tool, mainly through 
extended validations and filters, the first phase of these reports will include an exploratory analysis in search 
of implausible values, outliers, and missing values that could influence the results and conclusions that are 
derived from them.  

 
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The categorical variables will be represented based on their absolute and relative frequencies, while for the 
quantitative variables, measures of central tendency and dispersion will be used in accordance with the 
distribution of the data. The existence of an association between a variable and a population parameter or 
between two different variables will be evaluated by hypotheses testing that will be adapted to the nature of 
each variable (Chi square, Fisher, t-Student, one-factor ANOVA, Mann-Whitney, Kruskal-Wallis). An α error 
of 0.05 will be accepted in all tests as a common rule. In the event of a statistically significant association 
involving variables with more than two categories, the corresponding post-hoc contrasts will be performed 
using adjustment techniques (Tukey, Bonferroni). The size of the effect between variables will be evaluated 
using the most widely accepted estimators (r-Pearson, Spearman's rho, Kendall's tau, Cohen's d and 
v'Cramer). 
The degree of association between dependent and independent variables will be determined using 
regression techniques (binary, multinomial, Poisson, Cox) reporting the effect size in terms of Odds Ratios 
or Hazard Ratios, as appropriate, with 95% confidence intervals. In addition to the classic regression models, 
new classification algorithms will be implemented, mainly based on supervised machine learning techniques 
(random forests and support vector machines). 
The validation of external predictive models will include goodness-of-fit techniques to assess the model's 
calibration and discrimination techniques, mainly based on the area under the ROC curve and the 
concordance index for non-binary dependent variables. In the case of models with a good degree of 
discrimination, their recalibration for use in our environment will be assessed. The accuracy of the 
predictions will be evaluated using specific estimators for each type of model. The internal validation of the 
models built from the registry data will be carried out using resampling or cross-validation techniques. The 
performance between institutions will be made for those outcomes that act as dependent variables of 
previously validated models. The effect of a given type of treatment on a dependent variable will be 
determined using propensity score techniques adapted to current European recommendations. 
The periodic scientific reports by the main investigator of this project will be carried out using the R software, 
with RStudio as the development environment and the help of the following libraries according to their main 
functions: data cleaning (Tidyverse), exploratory analysis (DataExplorer and MICE), descriptive analysis 
(Summarytools, CompareGroups, Finalfit), visualization (GGplot2 and Plotly) and modeling (Tidymodels, 
Caret, Mlr3). The development of interactive web applications will be carried out using the reactive 
programming system Shiny for R. 
All the research works derived from the current ReSECT project will be adapted to the current internationally 
established recommendations for transparency in publication. 
 
 

 
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8.  Audit 
One of the main priorities of the current registry will focus on obtaining quality data that are representative 
of the registry's target population. 
A.  In data collection. 
The first phase of quality control will be related to the moment of data collection and will be determined by: 
• 
Registry design: restrictions and warnings to avoid unlikely or inconsistent values between two or 
more variables; extended validations to avoid input errors. 
• 
Web tool: filters and descriptive statistics available to the user within the platform itself. These 
options allow, for example, the user to know the percentage of missing values in those variables 
that they are interested in knowing directly from the platform or once the filtered data has been 
exported. 
• 
Periodic scientific reports prepared by the scientific director: a section of these reports will be 
devoted to evaluating the percentage of missing values in certain variables in each department. 
 
B.  Internal audit systems 
•  Annual reports issued by the person in charge of the clinical documentation service of each 
participating center and addressed to the ReSECT executive committee. These reports must reflect 
the number of candidate procedures to be part of a certain ReSECT process in each calendar year, 
allowing the recruitment percentage of each center to be known. 
•  Audit of variables or sets of variables considered key due to their scientific interest, or due to the 
possibility of entailing conflicts of interest for the participating professionals or institutions. This 
audit step may be carried out based on pseudonymized registration reports sent to the general 
secretary of ReSECT and/or through videoconferences under a secure environment established 
by the management of the center to be audited. 
9.  Limitations 
Due to the voluntary nature of the current registry, its main limitation will be determined by the 
representativeness of the study population, which in turn will depend on the number and type of participating 
institutions, and the recruitment percentage of each of them. The compromise of representativeness could 
suppose the introduction of systematic biases that jeopardize the external validity or generalization of our 
results, and therefore the possibility of exporting our findings to other scenarios. 

 
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Another of the limitations that the current registry must face is the information bias resulting from the 
inclusion of untrue data, intentionally or not. Such limitation may compromise, especially, certain variables 
whose real values may suppose a conflict of interest with the professionals or institutions that participate. 
Sharing the same reasoning, selection bias would mean that the inclusion of patients could be conditioned 
by their baseline characteristics, with individuals with a more favourable clinical profile being more likely to 
be invited to participate in the registry, or preferentially recruiting those patients who have presented a more 
beneficial postoperative course or have undergone surgical techniques of special interest. 
The observational nature of this registry also jeopardizes the internal validity of our results because of the 
confusion bias by indication (channeling bias), consisting of the tendency of professionals to indicate certain 
drugs, or type of surgical procedure in our case, based on the prognosis of a given patient. For example, 
sublobar vs. lobar resection, VATS approach vs. thoracotomy, and VATS approach vs. robotic surgery, 
among others. 
Finally, and also secondary to the observational nature of the study, certain potential confounding factors 
not included in our study, intentionally for reasons of practicality given the high probability of missing values 
or as a consequence of a not favourable effort-benefit balance in their collection, and unintentionally, in case 
of non-quantifiable variables, they could compromise the size of the effect associated with certain risk factors 
and/or types of treatment, or the external validity of some of the predictive models derived from our cohort. 
The audit systems established by the current registry, and described in the procedures section of this 
protocol, are intended to overcome these potential limitations in terms of internal and external validity before 
the start-up of this registry. We believe that the a priori knowledge of these audit systems will have a positive 
impact on the quality of the data collected. On the other hand, the mandatory active collaboration of a 
professional in data analysis in all research projects derived from the current registry, will favour to minimize 
the impact of such limitations and, in any case, improve the interpretation of our results under such 
conditions. 
10.  Regulation 
The executive committee of ReSECT will be the part responsible for making decisions that affect the 
objectives, regulation, and structure of ReSECT. This committee is constituted as a semi-permanent 
commission made up of a scientific director, institutional coordinator, and general secretary. 
In addition to the executive committee, the structure of ReSECT is defined by a triennial scientific committee 
made up of five thoracic surgeons with professional practice in the national territory and number members 
of the Spanish Society of Thoracic Surgery. The election of the members of the scientific committee will be 

 
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the responsibility of the executive committee, except in the case of the representative of the Board of 
Directors of SECT in that committee. 
11.  Patient privacy 
On the ReSECT platform, each professional, through a username and password, will only have access to 
the information of the patients who underwent surgery in their institution. The patients registered by each 
user will be identified on the platform by the “hospital of origin” and a “representative code”. Such code will 
be generated by means of a logical rule and/or linear combination applied to a certain identification 
document. Both the rule to be applied and the document from which that code is generated will be agreed 
and confidential between the professionals of each service. No other direct identification data such as name, 
surname or personal documents will be collected.  
The only user with the capacity to export all the data from the platform will be the scientific director of 
ReSECT, who will be responsible for the transfer of pseudonymized data to those users who have proposed 
specific internal research projects based on the registry data and have the approval of the executive and 
scientific committee of ReSECT. Therefore, the transfer of clinical data for the purpose of those projects will 
be carried out without the end user being able to associate any clinical data with a specific patient.  
The data transfer process will be carried out through the export seed of the web platform itself, managed by 
the specialized digital health company Persei Vivarium (CIF-B87263885. c/ Gran Vía 62, 28013 Madrid). 
 
 
 
 
 
 
 
 
 
 

 
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12.  Ethics committee approval 
 
 
 

 
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13.  Information document for the participant 
Project title: REGISTRO DE LA SOCIEDAD ESPAÑOLA DE CIRUGÍA TORÁCICA  
Promotor: SOCIEDAD ESPAÑOLA DE CIRUGÍA TORÁCICA 
Principal Investigator:  
Institution  
 
1. Introduction: 
We are writing to you to request your participation in a research project that we are carrying out at the 
hospital……………………. Your participation is completely voluntary, in no case should you feel obligated 
to participate, but it is important to obtain the knowledge we need. This project has been approved by an 
Ethics Committee. Before making a decision, it is necessary that: 
- Read this entire document. 
- Understand the information contained in the document. 
- Ask all the questions you consider necessary. 
- Make a thoughtful decision. 
- Sign the informed consent, if you finally want to participate. 
If you decide to participate, you will be given a copy of this sheet and the signed consent document. Please 
keep it in case you need it in the future. 
 
2. Why are you being asked to participate? 
Your collaboration is requested because you are scheduled to undergo a surgical procedure on the thorax 
or one of its border regions. The study consists of a permanent record of the national surgical activity of our 
specialty, which is why it is being carried out in most of the Thoracic Surgery Services in the country. 
 
 

 
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3. What is the object of this study? 
The objective of this study is to know the clinical care practice of our specialty and thus be able to obtain 
quality clinical data that allow us to improve the care we offer our patients. In addition, this study intends to 
collaborate in the future with the registry of the European Society of Thoracic Surgery through the transfer 
of data to it. 
 
4. What do I have to do if I decide to participate? 
Participating in this study only implies accepting that your clinical data will be included in a health data 
platform managed by a company specialized in digital health (Persei vivarium). 
 
5. What risks or inconveniences does it entail? 
By participating in the study you will not undergo any additional type of invasive or non-invasive intervention, 
nor does it require you to attend more medical visits than you should already attend according to the 
protocols of the hospital where you are being treated. 
 
6. Will I get any benefit from my participation? 
You will not receive any benefits from taking part in this study, nor are you likely to receive benefits in the 
future. 
 
7. How will my personal data be treated? 
The data that will be collected about your health has to do with your previous illnesses and the type of tests 
that have been carried out before the operation (anthropometric data, imaging tests, respiratory function 
study...), the type of surgery that will be performed (surgical approach, type of anaesthesia, duration of 
surgery, type of procedure...), the postoperative course in the hospital after the surgical intervention (type 
of care, complications, days of hospital stay...) and the evolution of your state of health once you are 
discharged from the hospital (hospital readmission, disease control, follow-up time...). 

 
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The data will be processed by a company specialized in digital health (Persei Vivarium). The person in 
charge of this study at the hospital where you are being treated will be Dr……………………., who will be at 
your complete disposal to clarify any doubts that may arise in relation to your collaboration. 
Purpose: Your personal data will be treated exclusively for the research work referred to in this document. 
Legitimation: The treatment of the data of this study is legitimized by your consent to participate. 
Recipients: Your clinical data may always be transferred anonymously to other health registries with similar 
characteristics and objectives to those of this national registry. 
Rights: You can exercise your rights of access, rectification, deletion and portability of your data, of limitation 
and opposition to its treatment, in accordance with the provisions of LO 3/2018 on Protection of Personal 
Data and guarantee of digital rights and the General Data Protection Regulation (RGPD 2016/679) before 
the main investigator of the project, being able to obtain information in this regard by sending an email to 
the address dpd@salud.aragon.es. If you wish to withdraw from the study, you can request the deletion of 
your data. 
You can consult additional and detailed information in the Registry of Processing Activities of the 
Government of Aragon, at the following link: 
https://aplicaciones.aragon.es/notif_lopd_pub/details.action?fileId=731 
Likewise, in compliance with the provisions of the RGPD, it is reported that, if you wish, you can go to the 
Data Protection Agency (https://www.aepd.es) to file a claim when you consider that it is not have duly 
respected your rights.  
The processing of your personal data will be carried out using techniques to maintain your anonymity using 
random codes, so that your personal identity is completely hidden during the investigation process. 
Based on the results of the research work, scientific communications may be prepared to be presented at 
congresses or scientific journals, but they will always be done with grouped data and nothing that can identify 
you will ever be disclosed.  
You can consult the privacy policy of the specialized company that will manage your health data at 
https://perseivivarium.com/privacy.php 
9. Who finances the study? 
This project is financed with funds from the Foundation of the Spanish Society of Thoracic Surgery. The 
knowledge derived from this study is not intended to generate commercial benefits. 

 
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10. Will I be informed of the results of the study? 
You have the right to know the results of this study, both the general results and those derived from your 
specific data. You also have the right not to know such results if you wish. For this reason, in the informed 
consent document we will ask you which option you prefer. In case you want to know the results, the 
investigator will send you these results. 
Sometimes when carrying out a research project, unexpected findings are found that may be relevant to the 
health of the participant. In the event that this occurs, we will contact you so that you can see your regular 
doctor. 
Can I change my mind? 
Your participation is completely voluntary, you can decide not to participate or withdraw from the study at 
any time without having to give reasons and without this affecting your health care. You just need to tell the 
principal investigator of the study your intention. In case you decide to withdraw from the study you can 
request the destruction of the data, samples or other information collected about you. 
What happens if I have any questions during my participation? 
The first page of this document contains the name and contact telephone number of the investigator 
responsible for the study. You can contact him if you have any questions about your participation. You can 
also contact the person in charge of the study at your hospital of origin: Dr ……………………………. 
Thank you very much for your attention, if you finally wish to participate, please sign the attached consent 
document and we reiterate our gratitude for contributing to generating scientific knowledge.

 
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INFORMED CONSENT DOCUMENT 
Project title: REGISTRO DE LA SOCIEDAD ESPAÑOLA DE CIRUGÍA TORÁCICA (ReSECT) 
I, ................................................................ I have read the information sheet given to me. 
I have been able to ask questions about the study and have received enough information about the study. 
I have spoken with: ...............................................(name of investigator) 
I understand that my participation is voluntary. I understand that I can withdraw from the study: 
1) whenever you want 
2) without having to explain 
3) without this affecting my medical care 
I freely give my consent to participate in this study and I give my consent for the access and use of my data 
as stipulated in the information sheet that has been given to me. 
I wish to be informed about the results of the study: Yes         No        (check as appropriate) 
I give my consent for my clinical data to be reviewed by personnel outside the center, for the purposes of 
the study, and I am aware that this consent is revocable. 
I have received a signed copy of this Informed Consent. 
 
Participant signature: ………………………………………………………. Date:  
 
Mr. / Ms…………………………………………. with ID…………………. I declare that the doctor,  
Dr/Dra...................................., has explained to me what the current study consists of and therefore I give 
my consent for the patient Mr./Mrs… …………….………… with ID…………...  to participate in the study. 
 
Signature of the legal representative …………………………………… Date:  
 
I have explained the nature and purpose of the study to the named patient  
 
Investigator signature: ………………………………………………………… Date: