Registry of the Spanish Society of Thoracic Surgery (ReSECT)

October 18, 2023 updated by: Sociedad Española de Cirugía Torácica

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:

  • 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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David Gómez de Antonio, PhD
  • Phone Number: +34 669 524334
  • Email: dgavm@yahoo.es

Study Contact Backup

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet. Hospital Clínico Universitario Lozano Blesa. IIS Aragón. Universidad Zaragoza.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Exclusion Criteria:

  • Patients who could reject to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
All the target population
Patients who will undergo any surgical procedure in a Spanish Thoracic Surgery Department

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From surgery date to hospital discharge day or within ninety days.
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.
From surgery date to hospital discharge day or within thirty days.
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.
Five-year follow-up after surgery
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.
Five-year follow-up after surgery
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.
Five-year follow-up after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of hospital readmission
Time Frame: From hospital discharge day to thirty days afterwards.
Readmissions within thirty days of discharge from hospital for reasons related to the surgical procedure.
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
Primary reason for readmission and severity of complications from readmission date to hospital discharge day
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 who required unplanned intensive care unit admission
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

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.
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.

Functional status will be referred to patient ability to perform basic and instrumental activities of daily living.

Patients will be classified into:

  1. 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).
  2. 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.
  3. Totally dependent: patient who requires help to carry out most of the basic activities of daily living.
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
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.
From three months before surgery to surgical intervention date
Rate of complete resection for lung cancer
Time Frame: During the surgery
Number of patients with lung cancer who underwent complete resection / number of patients with lung cancer who underwent surgical resection.
During the surgery
Distribution of patients according to type of lymphadenectomy
Time Frame: During the surgery

Patients operated on for lung cancer will be classified according to type of lymphadenectomy performed into:

  1. Minor Lymphadenectomy.

  2. 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.
  3. 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.
During the surgery
Rate of occult pN2 disease
Time Frame: During the surgery
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.
During the surgery
Mean postoperative stay
Time Frame: From day of surgery to day of hospital discharge or within 3 months.
Number of days of hospitalization after surgery
From day of surgery to day of hospital discharge or within 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Cirugía Torácica

Investigators

  • Study Director: Raúl Embún, PhD, Hospital Universitario Miguel Servet / raulembun@gmail.com / Phone: +34 635 492179

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sect/resect/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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