QUALITYSURG is a multicenter interventional study evaluating whether a collaborative intraoperative quality checklist (QualitySurg List) can improve the oncological quality of lung cancer resections. The study includes three phases: a Delphi consensus to define checklist contents, a cluster-randomized trial comparing checklist use versus standard care, and a prospective implementation phase assessing long-term adoption. The primary endpoint is the proportion of confirmed R0 resections according to 2020 IASLC criteria.Two optional ancillary studies are embedded within the main protocol. BIO-QualitySurg aims to evaluate biological markers of residual disease and develop the concept of a biological R0 resection using circulating tumor DNA (ctDNA), tissue biomarkers, and integrated molecular analyses. BIO-QualitySurg is complementary to the objectives of the European REALCARE project, which investigates ctDNA-based approaches for residual disease assessment and personalized cancer management. VIDEO-QualitySurg contributes to the broader objective of improving quality assessment and standardization of thoracic oncologic surgery through digital technologies and artificial intelligence.
Age ≥18 years
Have solid NSCLC clinical stage IA-IIIA (according to the 9th edition of the TNM) and be eligible for surgical resection.
Have a respiratory function and a state of performance (ECOG) allowing the surgical procedure.
Primary intervention for NSCLC, whether isolated or included in a multimodal regimen (neoadjuvant/adjuvant).
History of cancer less than five years old excluding non-melanocytic skin cancer prior to enrollment
Pure ground glass opacities regardless of tumor size
iterative re-interventions of the same stay (keep only the first planned intervention for the main analysis)
History of HIV infection, allogeneic stem cell or solid organ transplant
Parallel
QualitySurg List
Other interventionThe QualitySurg List is a collaborative intraoperative quality assessment tool for lung cancer surgery that combines a checklist, a to-do list, and a reporting system. The intervention includes implementation of the QualitySurg List, training of operating room personnel, access to a dedicated digital application integrated within the Epithor platform, and performance feedback through benchmarking of quality indicators. The tool is designed to support real-time assessment and documentation of surgical quality and to improve achievement of oncologically complete (R0) resections.
Proportion of Confirmed R0 Resections
R0 status assessed according to IASLC 2020 criteria using centralized pathology review and independent adjudication.
QualitySurg list Implementation and Adoption
Measure individual and collective adherence to the list (usage rate, level of completeness).
Medium-Term Oncological Results
overall survival (OS) and disease-free survival (DFS) at 2 years, and proportion of local or metastatic recurrences at 2 years.
Quality of the Surgical Procedure
Evaluate the impact on intraoperative and post-operative complications (morbidity, mortality, length of stay, especially in intensive care).
Sociological and Collaborative Aspects
Evaluate the impact on: * Interprofessional communication : obeservations, semi-structured interviews, self-administred questionnaire (Likert scale) * Team engagement: obeservations, semi-structured interviews, self-administred questionnaire (Likert scale) * Acceptability of the list in the operating room: obeservations, semi-structured interviews, self-administred questionnaire (Likert scale)
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