Registry of the Spanish Society of Thoracic Surgery

NCT ID: NCT05600569

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2032-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All the target population

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients who could reject to participate in this study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Española de Cirugía Torácica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raúl Embún, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Zaragoza, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

David Gómez de Antonio, PhD

Role: CONTACT

dgavm@yahoo.es

+34 669 524334

Miguel Congregado, PhD

Role: CONTACT

mcongregado@me.com

+34 667 434033

Facility Contacts

Raul Embun, PhD

Role: primary

raulembun@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 35579917 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33752924 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35698981 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35643356 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35787477 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35091211 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36003470 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35671974 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35301527 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35218337 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35213711 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35379545 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

https://www.sect.es

Spanish Society of Thoracic Surgery

Other Identifiers

sect/resect/01

Identifier Type: -

Identifier Source: org_study_id