Assessment of the Prognostic Impact of the Published European Society of Gynecologic Oncology Quality Indicators for Advanced Ovarian Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11,383
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Abstract
Background:
Multiple studies have confirmed that centralization improves outcomes in women with advanced stage ovarian carcinoma (OC), in part due to complex treatment algorithms including extensive cytoreductive surgery. Therefore, the European Society of Gynaecological Oncology (ESGO) has established and published ten quality indicators for centers performing advanced ovarian cancer surgery. Based on these quality indicators, ESGO runs institutional accreditation processes for advanced ovarian cancer surgery in two categories, i.e. regular accreditation for advanced ovarian cancer surgery and centers of excellence for advanced ovarian cancer surgery. ESGO also runs institutional accreditation processes for endometrial cancer surgery and for training centers in gynaecological oncology. Of note, no large international multicenter study has validated the ESGO quality indicators of advanced ovarian cancer surgery as of yet.
Study design/objectives:
The present study is set out to assess the prognostic impact of the established ESGO quality indicators for advanced ovarian cancer surgery in a large international, multicenter study comprising ESGO accredited centers. All ESGO accredited centers will be invited to participate in the present study. Participating centers will provide clinical data on the 10 ESGO quality indicators in ovarian cancer surgery and follow- up data on progression-free (PFS) and overall survival (OS) for the past three years, i.e. 2020, 2021, and 2022. To avoid selection bias, the following two patient cohorts will be included in the present study 1) ALL consecutively incoming patients at the center with newly diagnosed advanced (stages III and IV) ovarian cancer (importantly, irrespective of whether they underwent surgery or not during their primary therapy), and 2) ALL recurrent OC patients who underwent secondary of tertiary cytoreductive surgery at the center (importantly, surgical cases only).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient presented at an ESGO-accredited centre between January 1, 2020 and December 31, 2022
- •Newly diagnosed FIGO stage III or IV ovarian cancer (surgical and non-surgical cases), OR
- •Relapsed ovarian cancer undergoing secondary or tertiary cytoreductive surgery (surgical cases only)
- •All consecutive incoming ovarian cancer patients within the specified time frame were documented to avoid selection bias
排除标准
- •Age <18 years at first diagnosis
- •Relapsed ovarian cancer undergoing surgery for palliative intent (no cytoreductive surgery)
- •Early-stage ovarian cancer at first diagnosis