Validation of ESGO Quality Indicators in Advanced Ovarian Cancer Surgery

NCT07567573 | Completed

• 1 other identifier: retroESGO ov1
• Study Type: observational
• Target: 11,383
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ovarian Cancer; Advanced Ovarian Cancer; FIGO Stage III; FIGO Stage IV; Cytoreductive Surgery; Complete Macroscopic Resection; Residual Disease; Progression-Free Survival; Overall Survival; Surgical Outcomes; Gynaecologic Oncology; Multidisciplinary Care; Quality Indicators; Perioperative Management; Hyperthermic Intraperitoneal Chemotherapy (HIPEC); HIPEC; Pathology Reporting; Operative Documentation; Cancer Surgery; ESGO Accreditation; Surgical Complexity Score; Tumor Debulking; Recurrent Ovarian Cancer; Cancer Survival; Chemotherapy; Retrospective Cohort Study; Clinical Trial Participation; Surgical Expertise; Gynaecological Cancer; Preoperative Assessment; Postoperative Complications; Tumor Recurrence; Surgical Volume; High-Volume Centers; Centralized Cancer Care; Surgical Quality; Evidence-Based Oncology; International Study; Cancer Prognosis; Accreditation Standards; Research Collaboration; Comprehensive Cancer Care; Tumor Biology; Advanced Cancer Management; Medical Outcomes; Surgical Metrics; Oncological Surgery; Medical Benchmarking; Health Outcomes Research; Cancer Care Quality; Advanced Ovarian Tumors; Tumor Biology and Staging; Pseudonymized Data Collection; Cancer Research Standards; Clinical Effectiveness; Ovarian Tumor Surgery; Precision Oncology; Retrospective Analysis

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Time from initial treatment (e.g., surgery or chemotherapy) to disease progression, recurrence, or death from any cause, whichever occurs first. Measurement Method: Data collected from patient records, including imaging reports, clinical evaluations, and follow-up documentation.

  Assessed over the study period (2020-2022) with a minimum follow-up of 20 months.

Secondary Outcomes (5)

• Overall Survival (OS)

  From start of treatment until death from any cause, assessed up to 5 years (data cut-off December 2024).

• Adherence to ESGO Quality Indicators

  During the study period (2020-2022).

• Rate of Complete Cytoreduction

  Assessed during the surgical intervention period (2020-2022).

• Postoperative Complication Rates

  Assessed within 30 days post-surgery.

• Impact of Accreditation Status on Outcomes

  From start of treatment until death from any cause, assessed up to 5 years (data cut-off December 2024).

Other Outcomes (2)

• Surgical Complexity Score

  At time of surgery, for surgeries performed during the enrollment period (January 2020 - December 2022).

• Multidisciplinary Team Participation

  Preoperative, for cases treated during the enrollment period (January 2020 - December 2022).

Study Arms (2)

Newly Diagnosed Advanced Ovarian Cancer

Participants with FIGO stage III or IV ovarian cancer who were newly diagnosed and managed at ESGO-accredited centers during the study period (2020-2022). This cohort includes patients irrespective of whether they underwent cytoreductive surgery during their primary treatment.

Procedure: Preoperative Evaluations; Procedure: Cytoreductive Surgery; Procedure: Perioperative Management; Procedure: Systemic Chemotherapy

Recurrent Ovarian Cancer

Participants with recurrent ovarian cancer who underwent secondary or tertiary cytoreductive surgery at ESGO-accredited centers during the study period (2020-2022). This cohort focuses on evaluating surgical and clinical outcomes in cases of disease recurrence.

Procedure: Preoperative Evaluations; Procedure: Cytoreductive Surgery; Procedure: Perioperative Management; Procedure: Systemic Chemotherapy

Interventions

Preoperative Evaluations PROCEDURE

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.

Newly Diagnosed Advanced Ovarian Cancer; Recurrent Ovarian Cancer

Cytoreductive Surgery PROCEDURE

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.

Newly Diagnosed Advanced Ovarian Cancer; Recurrent Ovarian Cancer

Perioperative Management PROCEDURE

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.

Newly Diagnosed Advanced Ovarian Cancer; Recurrent Ovarian Cancer

Systemic Chemotherapy PROCEDURE

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.

Newly Diagnosed Advanced Ovarian Cancer; Recurrent Ovarian Cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are individuals treated for advanced or recurrent ovarian cancer at ESGO-accredited centers across multiple countries. These centers include institutions with standard accreditation and centers of excellence, representing a diverse geographical and clinical practice setting. The study population reflects patients managed within routine clinical care during the period 2020-2022.

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years at first diagnosis
• Relapsed ovarian cancer undergoing surgery for palliative intent (no cytoreductive surgery)
• Early-stage ovarian cancer at first diagnosis

Sponsors & Collaborators

• ESGO Consortium of Accredited Centres: collaborator
• European Society of Gynaecological Oncology: lead

Study Sites (1)

European Society of Gynaecological Oncology Aisbl

Brussels, 1200, Belgium

Location

Related Publications (8)

• Wright JD, Chen L, Hou JY, Burke WM, Tergas AI, Ananth CV, Neugut AI, Hershman DL. Association of Hospital Volume and Quality of Care With Survival for Ovarian Cancer. Obstet Gynecol. 2017 Sep;130(3):545-553. doi: 10.1097/AOG.0000000000002164.

  PMID: 28796677 BACKGROUND

• Querleu D, Planchamp F, Chiva L, Fotopoulou C, Barton D, Cibula D, Aletti G, Carinelli S, Creutzberg C, Davidson B, Harter P, Lundvall L, Marth C, Morice P, Rafii A, Ray-Coquard I, Rockall A, Sessa C, van der Zee A, Vergote I, du Bois A. European Society of Gynaecologic Oncology Quality Indicators for Advanced Ovarian Cancer Surgery. Int J Gynecol Cancer. 2016 Sep;26(7):1354-63. doi: 10.1097/IGC.0000000000000767.

  PMID: 27648648 BACKGROUND

• Palmqvist C, Staf C, Mateoiu C, Johansson M, Albertsson P, Dahm-Kahler P. Increased disease-free and relative survival in advanced ovarian cancer after centralized primary treatment. Gynecol Oncol. 2020 Nov;159(2):409-417. doi: 10.1016/j.ygyno.2020.09.004. Epub 2020 Sep 15.

  PMID: 32943206 BACKGROUND

• Marth C, Abreu MH, Andersen KK, Aro KM, de Lurdes Batarda M, Boll D, Ekmann-Gade AW, Haltia UM, Hansen J, Haug AJ, Hogdall C, Korach J, Lassus H, Lindemann K, Van Nieuwenhuysen E, Ottevanger PB, Polterauer S, Schnack TH. Real-life data on treatment and outcomes in advanced ovarian cancer: An observational, multinational cohort study (RESPONSE trial). Cancer. 2022 Aug 15;128(16):3080-3089. doi: 10.1002/cncr.34350. Epub 2022 Jun 17.

  PMID: 35714310 BACKGROUND

• Gac MM, Loaec C, Silve J, Vaucel E, Augereau P, Wernert R, Bourgin C, Aireau X, Lortholary A, Descamps P, Priou F, Deblaye P, Bourgeois H, Delecroix V, Empereur F, Campion L, Classe JM. Quality of advanced ovarian cancer surgery: A French assessment of ESGO quality indicators. Eur J Surg Oncol. 2021 Feb;47(2):360-366. doi: 10.1016/j.ejso.2020.08.003. Epub 2020 Aug 11.

  PMID: 32863097 BACKGROUND

• Fotopoulou C, Concin N, Planchamp F, Morice P, Vergote I, du Bois A, Querleu D. Quality indicators for advanced ovarian cancer surgery from the European Society of Gynaecological Oncology (ESGO): 2020 update. Int J Gynecol Cancer. 2020 Apr;30(4):436-440. doi: 10.1136/ijgc-2020-001248. Epub 2020 Feb 20. No abstract available.

  PMID: 32086362 BACKGROUND

• Bristow RE, Zahurak ML, Diaz-Montes TP, Giuntoli RL, Armstrong DK. Impact of surgeon and hospital ovarian cancer surgical case volume on in-hospital mortality and related short-term outcomes. Gynecol Oncol. 2009 Dec;115(3):334-8. doi: 10.1016/j.ygyno.2009.08.025. Epub 2009 Sep 18.

  PMID: 19766295 BACKGROUND

• Alejandra M, Gertych W, Pomel C, Ferron G, Lusque A, Angeles MA, Lambaudie E, Rouzier R, Bakrin N, Golfier F, Glehen O, Canis M, Bourdel N, Pouget N, Colombo PE, Guyon F, Meurette J, Querleu D. Adherence to French and ESGO Quality Indicators in Ovarian Cancer Surgery: An Ad-Hoc Analysis from the Prospective Multicentric CURSOC Study. Cancers (Basel). 2021 Mar 30;13(7):1593. doi: 10.3390/cancers13071593.

  PMID: 33808284 BACKGROUND

Related Links

• Official website of the project

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasm, Residual; Postoperative Complications; Recurrence

Interventions

Cytoreduction Surgical Procedures; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics

Study Officials

• Nicole Concin

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: May 5, 2026
• Study Start: April 26, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)