Pulmonary Surgical ProceduresReSECTNCT05600569
Registry of the Spanish Society of Thoracic Surgery
An observational study of Pulmonary Surgical Procedures and Thoracic Surgery, Video-assisted, run by Sociedad Española de Cirugía Torácica at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Surgical Procedures, Thoracic Surgery, Video-assisted, Robotic Surgical Procedures
- How many people
- 30,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2023to 31 Dec 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients that could requiere an intervention in the Spanish Thoracic Surgery Departments
Who may be able to join
None listed.
Who cannot join
- Patients who could reject to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Miguel Servet. Hospital Clínico Universitario Lozano Blesa. IIS Aragón. Universidad Zaragoza.
Zaragoza, 50009
Raul Embun, PhD, raulembun@gmail.com
About this study
Official title: Registry of the Spanish Society of Thoracic Surgery (ReSECT)
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Pulmonary Surgical Procedures, Thoracic Surgery, Video-assisted, Robotic Surgical Procedures, Thoracotomy, Lung Neoplasm
- Keywords
- Pneumonectomy, Lobectomy, Segmentectomy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All the target population | Patients who will undergo any surgical procedure in a Spanish Thoracic Surgery Department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of perioperative mortality
Mortality during hospitalization or that occurred within thirty and ninety days after surgery.
Measured: From surgery date to hospital discharge day or within ninety days.
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.
Measured: From surgery date to hospital discharge day or within thirty days.
Overall survival
Overall survival after anatomical resection for lung cancer. The outcome will include exitus for any reason.
Measured: Five-year follow-up after surgery
Disease specific survival
Disease free survival after anatomical resection for lung cancer. The outcome will include exitus for lung cancer progesssion.
Measured: Five-year follow-up after surgery
Recurrence free survival
Recurrence free survival after anatomical resection for lung cancer. The outcome will include recurrence of lung cancer.
Measured: Five-year follow-up after surgery.
Secondary outcomes (10)
Rate of hospital readmission
Readmissions within thirty days of discharge from hospital for reasons related to the surgical procedure.
Measured: From hospital discharge day to thirty days afterwards.
Diagnosis and severity of complications during hospital readmission.
Primary reason for readmission and severity of complications from readmission date to hospital discharge day
Measured: From hospital readmission date to hospital discharge day or within 30 days
Unplanned Intensive Care
Rate of patients who required unplanned intensive care unit admission
Measured: From day of surgery to day of hospital discharge or within 30 days
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.
Measured: From surgery date to hospital discharge day and from hospital readmission date to hospital discharge day or within 30 days
Rate of patients with functional status classified as independent, partially independent of totally dependent
Functional status will be referred to patient ability to perform basic and instrumental activities of daily living.
Patients will be classified into:
- Independent: autonomous patient to carry out most of the instrumental activities of daily living (pet care, raising kids, use of communication systems, mobility in the community, management of financial issues, health care and support, maintain a home, food preparation and cleaning, security procedures and emergency responses, go shopping).
- Partially dependent: autonomous patient for most of the basic activities of daily living (bath / shower, locker room, feeding, sphincters control, functional mobility, care of personal technical aids, personal hygiene and grooming, sexual activity, go sleeping, toilet hygiene), but unable to perform most instrumental activities of daily living.
- Totally dependent: patient who requires help to carry out most of the basic activities of daily living.
Measured: The day of hospital discharge or within 30 days after surgery.
Rate of patients with invasive mediastinal staging
Number of patients with diagnosis of lung cancer who underwent invasive staging of the mediastinum / number of patients with lung cancer who meet criteria for invasive staging of the mediastinum according to current guidelines.
Measured: From three months before surgery to surgical intervention date
Rate of complete resection for lung cancer
Number of patients with lung cancer who underwent complete resection / number of patients with lung cancer who underwent surgical resection.
Measured: During the surgery
Distribution of patients according to type of lymphadenectomy
Patients operated on for lung cancer will be classified according to type of lymphadenectomy performed into:
- Minor Lymphadenectomy.
- Lobe-specific systematic lymph node dissection: exeresis of the mediastinal tissue that contains the lymph nodes of certain lymph node stations is performed, depending on the location of the tumor.
- Tumor in the right upper lobe or middle lobe: 2R, 4R and 7.
- Tumor in the lower right lobe: 4R, 7, 8 and 9.
- Tumor in the upper left lobe: 5, 6 and 7.
- Tumor in the lower left lobe: 7, 8 and 9.
- Systematic lymph node dissection: dissection and exeresis of the mediastinal tissue that contains the lymph nodes following the anatomical limits. It is recommended that at least 3 mediastinal lymph node stations be excised, always including the subcarinal, in addition to the hilar and intrapulmonary stations.
Measured: During the surgery
Rate of occult pN2 disease
Number of patients operated on for lung cancer with pathological N2 disease and clinical N0-N1 disease / Number of patients operated on for lung cancer with clinical N0-N1 disease.
Measured: During the surgery
Mean postoperative stay
Number of days of hospitalization after surgery
Measured: From day of surgery to day of hospital discharge or within 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raúl Embún, PhD, Study director, Hospital Universitario Miguel Servet / raulembun@gmail.com / Phone: +34 635 492179
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600569
- Sponsor's protocol ID
- sect/resect/01
- Acronym
- ReSECT
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Embun R, Royo-Crespo I, Recuero Diaz JL, Bolufer S, Call S, Congregado M, Gomez-de Antonio D, Jimenez MF, Moreno-Mata N, Aguinagalde B, Amor-Alonso S, Arraras MJ, Blanco Orozco AI, Boada M, Cabanero Sanchez A, Cal Vazquez I, Cilleruelo Ramos A, Crowley Carrasco S, Fernandez-Martin E, Garcia-Barajas S, Garcia-Jimenez MD, Garcia-Prim JM, Garcia-Salcedo JA, Gelbenzu-Zazpe JJ, Giraldo-Ospina CF, Gomez Hernandez MT, Hernandez J, Wolf JDI, Jauregui Abularach A, Jimenez U, Lopez Sanz I, Martinez-Hernandez NJ, Martinez-Tellez E, Milla Collado L, Mongil Poce R, Moradiellos-Diez FJ, Moreno-Balsalobre R, Moreno Merino SB, Obiols C, Quero-Valenzuela F, Ramirez-Gil ME, Ramos-Izquierdo R, Rivo E, Rodriguez-Fuster A, Rojo-Marcos R, Sanchez-Lorente D, Sanchez Moreno L, Simon C, Trujillo-Reyes JC, Hernando Trancho F. Spanish Video-Assisted Thoracic Surgery Group: Method, Auditing, and Initial Results From a National Prospective Cohort of Patients Receiving Anatomical Lung Resections. Arch Bronconeumol. 2020 Nov;56(11):718-724. doi: 10.1016/j.arbr.2020.01.009.
PubMed 35579917Gomez de Antonio D, Crowley Carrasco S, Romero Roman A, Royuela A, Sanchez Calle A, Obiols Fornell C, Call S, Embun R, Royo I, Recuero JL, Cabanero A, Moreno N, Bolufer S, Congregado M, Jimenez MF, Aguinagalde B, Amor-Alonso S, Arraras MJ, Blanco Orozco AI, Boada M, Cal I, Cilleruelo Ramos A, Fernandez-Martin E, Garcia-Barajas S, Garcia-Jimenez MD, Garcia-Prim JM, Garcia-Salcedo JA, Gelbenzu-Zazpe JJ, Giraldo-Ospina CF, Gomez Hernandez MT, Hernandez J, Illana Wolf JD, Jauregui Abularach A, Jimenez U, Lopez Sanz I, Martinez-Hernandez NJ, Martinez-Tellez E, Milla Collado L, Mongil Poce R, Moradiellos-Diez FJ, Moreno-Basalobre R, Moreno Merino SB, Quero-Valenzuela F, Ramirez-Gil ME, Ramos-Izquierdo R, Rivo E, Rodriguez-Fuster A, Rojo-Marcos R, Sanchez-Lorente D, Moreno LS, Simon C, Trujillo-Reyes JC, Lopez Garcia C, Fibla Alfara JJ, Sesma Romero J, Hernando Trancho F. Surgical Risk Following Anatomic Lung Resection in Thoracic Surgery: A Prediction Model Derived from a Spanish Multicenter Database. Arch Bronconeumol. 2022 May;58(5):398-405. doi: 10.1016/j.arbres.2021.01.037. Epub 2021 Feb 24. English, Spanish.
PubMed 33752924Aguinagalde B, Insausti A, Lopez I, Sanchez L, Bolufer S, Embun R; en representacion del Grupo Espanol de Cirugia Toracica Video-asistida. VATS lobectomy morbidity and mortality is lower in patients with the same ppoDLCO: Analysis of the database of the Spanish Video-Assisted Thoracic Surgery Group. Arch Bronconeumol. 2021 Dec;57(12):750-756. doi: 10.1016/j.arbr.2021.10.005. Epub 2021 Oct 30.
PubMed 35698981Gomez Hernandez MT, Novoa Valentin NM, Fuentes Gago MG, Embun Flor R, Gomez de Antonio D, Jimenez Lopez MF; Spanish Group of Video-assisted Thoracic Surgery. Predictive factors of pathological complete response after induction (ypT0N0M0) in non-small cell lung cancer and short-term outcomes: Results of the Spanish Group of Video-assisted Thoracic Surgery (GE-VATS). Cir Esp (Engl Ed). 2022 Jun;100(6):345-351. doi: 10.1016/j.cireng.2022.05.025. Epub 2022 May 25.
PubMed 35643356Gomez Hernandez MT, Novoa Valentin NM, Embun Flor R, Varela Simo G, Jimenez Lopez MF; Grupo Espanol de Cirugia Toracica Videoasistida (GEVATS). Predictive factors of prolonged postoperative length of stay after anatomic pulmonary resection. Cir Esp (Engl Ed). 2023 Jan;101(1):43-50. doi: 10.1016/j.cireng.2022.06.048. Epub 2022 Jul 3.
PubMed 35787477Obiols C, Call S, Rami-Porta R, Jaen A, Gomez de Antonio D, Crowley Carrasco S, Royo-Crespo I, Embun R. Radicality of lymphadenectomy in lung cancer resections by thoracotomy and video-assisted thoracoscopic approach: A prospective, multicentre and propensity-score adjusted study. Lung Cancer. 2022 Mar;165:63-70. doi: 10.1016/j.lungcan.2022.01.004. Epub 2022 Jan 7.
PubMed 35091211Sesma J, Bolufer S, Garcia-Valentin A, Embun R, Lopez IJ, Moreno-Mata N, Jimenez U, Trancho FH, Martin-Ucar AE, Gallar J; Spanish Video-Assisted Thoracic Surgery Group. Thoracoscopic segmentectomy versus lobectomy: A propensity score-matched analysis. JTCVS Open. 2022 Jan 22;9:268-278. doi: 10.1016/j.xjon.2022.01.009. eCollection 2022 Mar.
PubMed 36003470Lopez I, Aguinagalde B, Urreta I, Royo I, Bolufer S, Sanchez L, Zabaleta J, Fernandez-Monge A, Recuero-Diaz JL, Sesma J, Amor S, Moradiellos FJ, Arraras MJ, Blanco AI, Boada M, Sanchez D, Cabanero A, Moreno N, Cal I, Moreno R, Cilleruelo A, Crowley S, Gomez D, Fernandez E, Hernando F, Garcia S, Lopez C, Garcia MD, Garcia JM, Rivo JE, Garcia JA, Gelbenzu JJ, Ramirez ME, Giraldo CF, Mongil R, Gomez MT, Jimenez M, Henandez J, Fibla JJ, Illana JD, Jauregui A, Jimenez U, Rojo R, Martinez NJ, Martinez E, Trujillo JC, Milla L, Moreno SB, Congregado M, Obiols C, Call S, Quero F, Ramos R, Rodriguez A, Simon CM, Embun R. Results in mediastinal lymph node staging of surgical lung cancer: Data from the prospective cohort of the Spanish Video-Assisted Thoracic Surgery Group. Cir Esp (Engl Ed). 2023 Jun;101(6):408-416. doi: 10.1016/j.cireng.2022.06.006. Epub 2022 Jun 6.
PubMed 35671974Gomez de Antonio D, Crowley Carrasco S, Romero Roman A, Royuela A, Gil Barturen M, Obiols C, Call S, Royo I, Recuero JL, Cabanero A, Moreno N, Embun R; Spanish Group of Video Assisted Thoracic Surgery (GEVATS). External validation of the European Society of Thoracic Surgeons morbidity and mortality risk models. Eur J Cardiothorac Surg. 2022 Aug 3;62(3):ezac170. doi: 10.1093/ejcts/ezac170.
PubMed 35301527Pons A, Guirao A, Fibla JJ, Carvajal C, Embun R, Sanchez D, Gevats, Hernandez J. National evaluation of risk factors for unplanned readmission after lung resection. Eur J Cardiothorac Surg. 2022 May 27;61(6):1251-1257. doi: 10.1093/ejcts/ezac081.
PubMed 35218337Recuero-Diaz JL, Royo-Crespo I, Gomez de-Antonio D, Call S, Aguinagalde B, Gomez-Hernandez MT, Hernandez-Ferrandez J, Sanchez-Lorente D, Sesma-Romero J, Rivo E, Moreno-Mata N, Embun R. Treatment and intention-to-treat propensity score analysis to evaluate the impact of video-assisted thoracic surgery on 90-day mortality after anatomical resection for lung cancer. Eur J Cardiothorac Surg. 2022 Aug 3;62(3):ezac122. doi: 10.1093/ejcts/ezac122.
PubMed 35213711Cabanero Sanchez A, Munoz Molina GM, Fra Fernandez S, Muriel Garcia A, Cilleruelo Ramos A, Martinez Hernandez N, Hernando Trancho F, Moreno Mata N; GE-VATS. Impact of neoadjuvant therapy on postoperative complications in non-small-cell lung cancer patients subjected to anatomic lung resection. Eur J Surg Oncol. 2022 Sep;48(9):1947-1953. doi: 10.1016/j.ejso.2022.03.008. Epub 2022 Mar 29.
PubMed 35379545
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of the Spanish Society of Thoracic Surgery (ReSECT)
- ClinicalTrials.gov ID
- NCT05600569
- Acronym / sponsor ID
- ReSECT / sect/resect/01
- Conditions
- Pulmonary Surgical Procedures, Thoracic Surgery, Video-assisted, Robotic Surgical Procedures, Thoracotomy, Lung Neoplasm
- Keywords
- Pneumonectomy, Lobectomy, Segmentectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Sociedad Española de Cirugía TorácicaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All the target population | – | –Patients who will undergo any surgical procedure in a Spanish Thoracic Surgery Department |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients that could requiere an intervention in the Spanish Thoracic Surgery Departments
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients who could reject to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of perioperative mortality
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Five-year follow-up after surgery.
Recurrence free survival after anatomical resection for lung cancer. The outcome will include recurrence of lung cancer.
10 secondary outcomes
Rate of hospital readmission
Time frame: From hospital discharge day to thirty days afterwards.
Diagnosis and severity of complications during hospital readmission.
Time frame: From hospital readmission date to hospital discharge day or within 30 days
Unplanned Intensive Care
Time frame: From day of surgery to day of hospital discharge or within 30 days
Rate of patients that required surgical reintervention
Time frame: From surgery date to hospital discharge day and from hospital readmission date to hospital discharge day or within 30 days
Rate of patients with functional status classified as independent, partially independent of totally dependent
Time frame: The day of hospital discharge or within 30 days after surgery.
Rate of patients with invasive mediastinal staging
Time frame: From three months before surgery to surgical intervention date
Rate of complete resection for lung cancer
Time frame: During the surgery
Distribution of patients according to type of lymphadenectomy
Time frame: During the surgery
Rate of occult pN2 disease
Time frame: During the surgery
Mean postoperative stay
Time frame: From day of surgery to day of hospital discharge or within 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Background: PubMed 35579917Embun R, Royo-Crespo I, Recuero Diaz JL, Bolufer S, Call S, Congregado M, Gomez-de Antonio D, Jimenez MF, Moreno-Mata N, Aguinagalde B, Amor-Alonso S, Arraras MJ, Blanco Orozco AI, Boada M, Cabanero Sanchez A, Cal Vazquez I, Cilleruelo Ramos A, Crowley Carrasco S, Fernandez-Martin E, Garcia-Barajas S, Garcia-Jimenez MD, Garcia-Prim JM, Garcia-Salcedo JA, Gelbenzu-Zazpe JJ, Giraldo-Ospina CF, Gomez Hernandez MT, Hernandez J, Wolf JDI, Jauregui Abularach A, Jimenez U, Lopez Sanz I, Martinez-Hernandez NJ, Martinez-Tellez E, Milla Collado L, Mongil Poce R, Moradiellos-Diez FJ, Moreno-Balsalobre R, Moreno Merino SB, Obiols C, Quero-Valenzuela F, Ramirez-Gil ME, Ramos-Izquierdo R, Rivo E, Rodriguez-Fuster A, Rojo-Marcos R, Sanchez-Lorente D, Sanchez Moreno L, Simon C, Trujillo-Reyes JC, Hernando Trancho F. Spanish Video-Assisted Thoracic Surgery Group: Method, Auditing, and Initial Results From a National Prospective Cohort of Patients Receiving Anatomical Lung Resections. Arch Bronconeumol. 2020 Nov;56(11):718-724. doi: 10.1016/j.arbr.2020.01.009.
- Background: PubMed 33752924Gomez de Antonio D, Crowley Carrasco S, Romero Roman A, Royuela A, Sanchez Calle A, Obiols Fornell C, Call S, Embun R, Royo I, Recuero JL, Cabanero A, Moreno N, Bolufer S, Congregado M, Jimenez MF, Aguinagalde B, Amor-Alonso S, Arraras MJ, Blanco Orozco AI, Boada M, Cal I, Cilleruelo Ramos A, Fernandez-Martin E, Garcia-Barajas S, Garcia-Jimenez MD, Garcia-Prim JM, Garcia-Salcedo JA, Gelbenzu-Zazpe JJ, Giraldo-Ospina CF, Gomez Hernandez MT, Hernandez J, Illana Wolf JD, Jauregui Abularach A, Jimenez U, Lopez Sanz I, Martinez-Hernandez NJ, Martinez-Tellez E, Milla Collado L, Mongil Poce R, Moradiellos-Diez FJ, Moreno-Basalobre R, Moreno Merino SB, Quero-Valenzuela F, Ramirez-Gil ME, Ramos-Izquierdo R, Rivo E, Rodriguez-Fuster A, Rojo-Marcos R, Sanchez-Lorente D, Moreno LS, Simon C, Trujillo-Reyes JC, Lopez Garcia C, Fibla Alfara JJ, Sesma Romero J, Hernando Trancho F. Surgical Risk Following Anatomic Lung Resection in Thoracic Surgery: A Prediction Model Derived from a Spanish Multicenter Database. Arch Bronconeumol. 2022 May;58(5):398-405. doi: 10.1016/j.arbres.2021.01.037. Epub 2021 Feb 24. English, Spanish.
- Background: PubMed 35698981Aguinagalde B, Insausti A, Lopez I, Sanchez L, Bolufer S, Embun R; en representacion del Grupo Espanol de Cirugia Toracica Video-asistida. VATS lobectomy morbidity and mortality is lower in patients with the same ppoDLCO: Analysis of the database of the Spanish Video-Assisted Thoracic Surgery Group. Arch Bronconeumol. 2021 Dec;57(12):750-756. doi: 10.1016/j.arbr.2021.10.005. Epub 2021 Oct 30.
- Background: PubMed 35643356Gomez Hernandez MT, Novoa Valentin NM, Fuentes Gago MG, Embun Flor R, Gomez de Antonio D, Jimenez Lopez MF; Spanish Group of Video-assisted Thoracic Surgery. Predictive factors of pathological complete response after induction (ypT0N0M0) in non-small cell lung cancer and short-term outcomes: Results of the Spanish Group of Video-assisted Thoracic Surgery (GE-VATS). Cir Esp (Engl Ed). 2022 Jun;100(6):345-351. doi: 10.1016/j.cireng.2022.05.025. Epub 2022 May 25.
- Background: PubMed 35787477Gomez Hernandez MT, Novoa Valentin NM, Embun Flor R, Varela Simo G, Jimenez Lopez MF; Grupo Espanol de Cirugia Toracica Videoasistida (GEVATS). Predictive factors of prolonged postoperative length of stay after anatomic pulmonary resection. Cir Esp (Engl Ed). 2023 Jan;101(1):43-50. doi: 10.1016/j.cireng.2022.06.048. Epub 2022 Jul 3.
- Background: PubMed 35091211Obiols C, Call S, Rami-Porta R, Jaen A, Gomez de Antonio D, Crowley Carrasco S, Royo-Crespo I, Embun R. Radicality of lymphadenectomy in lung cancer resections by thoracotomy and video-assisted thoracoscopic approach: A prospective, multicentre and propensity-score adjusted study. Lung Cancer. 2022 Mar;165:63-70. doi: 10.1016/j.lungcan.2022.01.004. Epub 2022 Jan 7.
- Background: PubMed 36003470Sesma J, Bolufer S, Garcia-Valentin A, Embun R, Lopez IJ, Moreno-Mata N, Jimenez U, Trancho FH, Martin-Ucar AE, Gallar J; Spanish Video-Assisted Thoracic Surgery Group. Thoracoscopic segmentectomy versus lobectomy: A propensity score-matched analysis. JTCVS Open. 2022 Jan 22;9:268-278. doi: 10.1016/j.xjon.2022.01.009. eCollection 2022 Mar.
- Background: PubMed 35671974Lopez I, Aguinagalde B, Urreta I, Royo I, Bolufer S, Sanchez L, Zabaleta J, Fernandez-Monge A, Recuero-Diaz JL, Sesma J, Amor S, Moradiellos FJ, Arraras MJ, Blanco AI, Boada M, Sanchez D, Cabanero A, Moreno N, Cal I, Moreno R, Cilleruelo A, Crowley S, Gomez D, Fernandez E, Hernando F, Garcia S, Lopez C, Garcia MD, Garcia JM, Rivo JE, Garcia JA, Gelbenzu JJ, Ramirez ME, Giraldo CF, Mongil R, Gomez MT, Jimenez M, Henandez J, Fibla JJ, Illana JD, Jauregui A, Jimenez U, Rojo R, Martinez NJ, Martinez E, Trujillo JC, Milla L, Moreno SB, Congregado M, Obiols C, Call S, Quero F, Ramos R, Rodriguez A, Simon CM, Embun R. Results in mediastinal lymph node staging of surgical lung cancer: Data from the prospective cohort of the Spanish Video-Assisted Thoracic Surgery Group. Cir Esp (Engl Ed). 2023 Jun;101(6):408-416. doi: 10.1016/j.cireng.2022.06.006. Epub 2022 Jun 6.
- Background: PubMed 35301527Gomez de Antonio D, Crowley Carrasco S, Romero Roman A, Royuela A, Gil Barturen M, Obiols C, Call S, Royo I, Recuero JL, Cabanero A, Moreno N, Embun R; Spanish Group of Video Assisted Thoracic Surgery (GEVATS). External validation of the European Society of Thoracic Surgeons morbidity and mortality risk models. Eur J Cardiothorac Surg. 2022 Aug 3;62(3):ezac170. doi: 10.1093/ejcts/ezac170.
- Background: PubMed 35218337Pons A, Guirao A, Fibla JJ, Carvajal C, Embun R, Sanchez D, Gevats, Hernandez J. National evaluation of risk factors for unplanned readmission after lung resection. Eur J Cardiothorac Surg. 2022 May 27;61(6):1251-1257. doi: 10.1093/ejcts/ezac081.
- Background: PubMed 35213711Recuero-Diaz JL, Royo-Crespo I, Gomez de-Antonio D, Call S, Aguinagalde B, Gomez-Hernandez MT, Hernandez-Ferrandez J, Sanchez-Lorente D, Sesma-Romero J, Rivo E, Moreno-Mata N, Embun R. Treatment and intention-to-treat propensity score analysis to evaluate the impact of video-assisted thoracic surgery on 90-day mortality after anatomical resection for lung cancer. Eur J Cardiothorac Surg. 2022 Aug 3;62(3):ezac122. doi: 10.1093/ejcts/ezac122.
- Background: PubMed 35379545Cabanero Sanchez A, Munoz Molina GM, Fra Fernandez S, Muriel Garcia A, Cilleruelo Ramos A, Martinez Hernandez N, Hernando Trancho F, Moreno Mata N; GE-VATS. Impact of neoadjuvant therapy on postoperative complications in non-small-cell lung cancer patients subjected to anatomic lung resection. Eur J Surg Oncol. 2022 Sep;48(9):1947-1953. doi: 10.1016/j.ejso.2022.03.008. Epub 2022 Mar 29.
- Spanish Society of Thoracic SurgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raúl Embún, PhD study director
Hospital Universitario Miguel Servet / raulembun@gmail.com / Phone: +34 635 492179
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Surgical Procedures and Thoracic Surgery, Video-assisted, run by Sociedad Española de Cirugía Torácica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Gómez de Antonio, PhD (+34 669 524334, dgavm@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of perioperative mortality (time frame: From surgery date to hospital discharge day or within ninety days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05600569, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.