Registry of the Spanish Society of Thoracic Surgery

Официальное название

Registry of the Spanish Society of Thoracic Surgery (ReSECT)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Rate of perioperative mortality [Срок оценки: From surgery date to hospital discharge day or within ninety days.]
• Rate and severity of perioperative morbidity [Срок оценки: From surgery date to hospital discharge day or within thirty days.]
• Overall survival [Срок оценки: Five-year follow-up after surgery]
• Disease specific survival [Срок оценки: Five-year follow-up after surgery]
• Recurrence free survival [Срок оценки: Five-year follow-up after surgery.]

Вторичные конечные точки (10)

• Rate of hospital readmission [Срок оценки: From hospital discharge day to thirty days afterwards.]
• Diagnosis and severity of complications during hospital readmission. [Срок оценки: From hospital readmission date to hospital discharge day or within 30 days]
• Unplanned Intensive Care [Срок оценки: From day of surgery to day of hospital discharge or within 30 days]
• Rate of patients that required surgical reintervention [Срок оценки: 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 [Срок оценки: The day of hospital discharge or within 30 days after surgery.]
• Rate of patients with invasive mediastinal staging [Срок оценки: From three months before surgery to surgical intervention date]
• Rate of complete resection for lung cancer [Срок оценки: During the surgery]
• Distribution of patients according to type of lymphadenectomy [Срок оценки: During the surgery]
• Rate of occult pN2 disease [Срок оценки: During the surgery]
• Mean postoperative stay [Срок оценки: From day of surgery to day of hospital discharge or within 3 months.]

Критерии участия

The inclusion criteria will depend on the section of the registry to be considered.

• 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.

Критерии исключения

• Patients who could reject to participate in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Hospital Universitario Miguel Servet. Hospital Clínico Universitario Lozano Blesa. IIS Ara — Zaragoza

Публикации

• 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 PMID 35579917
• 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 PMID 33752924
• 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
• 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( PMID 35643356
• 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
• 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
• 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
• 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 PMID 35671974

Идентификаторы

NCT: NCT05600569 · sect/resect/01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗