Clinical Trial

Validation of ESGO Quality Indicators in Advanced Ovarian Cancer Surgery

Study acronym: retroESGO ov1
Completed
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Summary
This study, organized by the European Society of Gynaecological Oncology (ESGO), evaluates the clinical impact of adherence to ten ESGO-established quality indicators (QIs) in advanced ovarian cancer surgery. These indicators are benchmarks for high-quality surgical care, addressing aspects such as surgical completeness, multidisciplinary management, documentation, and perioperative care. The study seeks to determine how adherence to these QIs influences progression-free survival and overall survival among patients with advanced ovarian cancer. Conducted as a retrospective, international, multicenter cohort study, this research involves ESGO-accredited centers and includes data from patients treated over three years (2020-2022). The study examines two cohorts: (1) all patients newly diagnosed with FIGO stage III or IV ovarian cancer, regardless of whether surgery was part of their initial treatment, and (2) recurrent ovarian cancer patients undergoing secondary or tertiary cytoreductive surgeries. By including all consecutive cases, the study minimizes selection bias and ensures robust, real-world insights. The primary objective is to assess the association between adherence to QIs and progression-free survival. Secondary objectives include evaluating the relationship between QIs and overall survival, analyzing adherence rates to individual and collective QIs, and examining the influence of ESGO accreditation status on outcomes. Participating centers will submit pseudonymized patient data via a secure REDCap database, ensuring compliance with GDPR and other data protection regulations. This research aims to validate ESGO's QIs as effective tools for enhancing surgical outcomes and promoting best practices in gynecological oncology. Findings will support the refinement of institutional accreditation criteria, guide health policies on care centralization, and improve treatment strategies for advanced ovarian cancer patients. Ultimately, the study is expected to contribute to improved survival outcomes and establish a stronger evidence base for quality-focused surgical care in gynecological oncology.
Trial Details
NCT Number NCT07567573
Lead Sponsor European Society of Gynaecological Oncology
Collaborators: ESGO Consortium of Accredited Centres
Conditions D010051, Ovarian Cancer, Advanced-stage Ovarian Cancer, FIGO Stages III and IV, Quality Indicators
Enrollment 11,383 participants
Start Date 2023-04-26
Primary Completion 2024-12-20 (estimated)
Study Completion 2024-12-20 (estimated)
Updated on ClinicalTrials.gov 2026-05-05