Validation of ESGO Quality Indicators in Advanced Ovarian Cancer Surgery

NCT07567573 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11383

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • D010051
  • Ovarian Cancer
  • Advanced-stage Ovarian Cancer
  • FIGO Stages III and IV
  • Quality Indicators

Interventions

PROCEDURE

Preoperative Evaluations

Participants underwent preoperative assessments to determine the extent of disease, eligibility for cytoreductive surgery, and overall fitness for treatment. These evaluations typically included imaging studies, laboratory tests, and multidisciplinary tumorboards at ESGO-accredited centers.

PROCEDURE

Cytoreductive Surgery

Surgical procedures aimed at achieving maximal tumor reduction, often targeting complete macroscopic resection (no visible residual disease). Cytoreductive surgery was performed on eligible patients as part of routine care for advanced or recurrent ovarian cancer.

PROCEDURE

Perioperative Management

Comprehensive perioperative care provided to optimize surgical outcomes and manage complications. This included pain management, critical care support, and postoperative monitoring to ensure patient safety and recovery.

PROCEDURE

Systemic Chemotherapy

Participants received chemotherapy regimens tailored to their clinical condition, either as neoadjuvant treatment (before surgery), adjuvant treatment (after surgery), or as part of palliative care. Chemotherapy was administered per routine protocols at ESGO-accredited centers.

Sponsors & Collaborators

Principal Investigators

  • Nicole Concin · Medical University of Vienna

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2024-12-20
Completion
2024-12-20

Countries

  • Belgium

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07567573 on ClinicalTrials.gov