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Trial Title:
Registry of the Spanish Society of Thoracic Surgery
NCT ID:
NCT05600569
Condition:
Pulmonary Surgical Procedures
Thoracic Surgery, Video-assisted
Robotic Surgical Procedures
Thoracotomy
Lung Neoplasm
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Pneumonectomy
Lobectomy
Segmentectomy
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
All the patients that could requiere an intervention in the Spanish Thoracic Surgery
Departments
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario Miguel Servet. Hospital Clínico Universitario Lozano Blesa. IIS Aragón. Universidad Zaragoza.
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Raul Embun, PhD
Email:
raulembun@gmail.com
Start date:
January 1, 2023
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Sociedad Española de Cirugía Torácica
Agency class:
Other
Source:
Sociedad Española de Cirugía Torácica
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05600569
https://www.sect.es