Registry of the Spanish Society of Thoracic Surgery

NCT05600569 | Recruiting DMC

• 1 other identifier: sect/resect/01
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Surgical Procedures; Thoracic Surgery, Video-assisted; Robotic Surgical Procedures; Thoracotomy; Lung Neoplasm

Keywords

Pneumonectomy; Lobectomy; Segmentectomy

Outcome Measures

Primary Outcomes (5)

• Rate of perioperative mortality

  Mortality during hospitalization or that occurred within thirty and ninety days after surgery.

  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.

  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.

  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.

  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.

  Five-year follow-up after surgery.

Secondary Outcomes (10)

• Rate of hospital readmission

  From hospital discharge day to thirty days afterwards.

• Diagnosis and severity of complications during hospital readmission.

  From hospital readmission date to hospital discharge day or within 30 days

• Unplanned Intensive Care

  From day of surgery to day of hospital discharge or within 30 days

• 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 functional status classified as independent, partially independent of totally dependent

  The day of hospital discharge or within 30 days after surgery.

Study Arms (1)

All the target population

Patients who will undergo any surgical procedure in a Spanish Thoracic Surgery Department

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients that could requiere an intervention in the Spanish Thoracic Surgery Departments

You may qualify if:

• 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.

You may not qualify if:

• Patients who could reject to participate in this study.

Sponsors & Collaborators

• Sociedad Española de Cirugía Torácica: lead

Study Sites (1)

Hospital Universitario Miguel Servet. Hospital Clínico Universitario Lozano Blesa. IIS Aragón. Universidad Zaragoza.

Zaragoza, 50009, Spain

RECRUITING

Related Publications (12)

• 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.

  PMID: 35579917 BACKGROUND

• Gomez 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.

  PMID: 33752924 BACKGROUND

• Aguinagalde 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.

  PMID: 35698981 BACKGROUND

• Gomez 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.

  PMID: 35643356 BACKGROUND

• Gomez 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.

  PMID: 35787477 BACKGROUND

• Obiols 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.

  PMID: 35091211 BACKGROUND

• Sesma 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.

  PMID: 36003470 BACKGROUND

• Lopez 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.

  PMID: 35671974 BACKGROUND

• Gomez 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.

  PMID: 35301527 BACKGROUND

• Pons 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.

  PMID: 35218337 BACKGROUND

• Recuero-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.

  PMID: 35213711 BACKGROUND

• Cabanero 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.

  PMID: 35379545 BACKGROUND

Related Links

• Spanish Society of Thoracic Surgery

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Raúl Embún, PhD

  Hospital Universitario Miguel Servet / raulembun@gmail.com / Phone: +34 635 492179

  STUDY DIRECTOR

Central Study Contacts

David Gómez de Antonio, PhD

CONTACT

+34 669 524334; dgavm@yahoo.es

Miguel Congregado, PhD

CONTACT

+34 667 434033; mcongregado@me.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 31, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)