BACKGROUND: The Global Gynaecological Oncology Surgical Outcomes Collaborative (GO SOAR) aims to develop a network of gynecological oncology surgeons, surgical departments, and other interested parties that will have the long-term ability to collaborate on outcome studies. The protocol for the first collaborative study is presented here. PRIMARY OBJECTIVE: To evaluate international variation in 30-day post-operative morbidity and mortality following gynecological oncology surgery between very high/high and medium/low human development index country settings. HYPOTHESIS: There is no variation in post-operative morbidity and mortality following gynecological oncology surgery between very high/high and medium/low human development index country settings. STUDY DESIGN: International, multicenter, prospective cohort study. Patient data will be collected over a consecutive 30-day period through gynecological oncology multidisciplinary teams/tumor boards and clinics across different human development index country groups. All data are collected on a customized, secure, password protected, central REDCap database. MAJOR INCLUSION/EXCLUSION CRITERIA: Inclusion criteria include women aged ≥18 years undergoing elective/emergency, curative/palliative surgery for primary/recurrent tubo-ovarian/peritoneal, endometrial, cervical, vulval, vaginal, gestational trophoblastic malignancies. Surgical modality may be open, minimal access (laparoscopic/robotic), or vaginal. PRIMARY ENDPOINT: 30-day post-operative morbidity and mortality defined as per Clavien-Dindo classification system. SAMPLE SIZE: 1100 (550/arm). ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: It is estimated recruitment will be completed by 2022 and results published by 2023. TRIAL REGISTRATION: ClinicalTrials.gov registry: NCT04579861 (https://clinicaltrials.gov/ct2/show/NCT04579861).

Aberdeen Health Data Science Research Centre University of Aberdeen Aberdeen UK

Department of Gynaecological Oncology Cancer Diseases Hospital Lusaka Zambia

Department of Gynaecological Oncology North East of Scotland Gynaecological Oncology Centre Aberdeen Royal Infirmary NHS Grampian Aberdeen UK

Department of Gynecologic Oncology and Reproductive Medicine MD Anderson Cancer Center Houston Texas USA

Department of Gynecologic Oncology Northwestern University in Chicago Evanston Illinois USA

Department of Obstetrics and Gynaecology General University Hospital Prague Czech Republic

Department of Paediatrics and Paediatric Infectious Diseases Institute of Child's Health Sechenov 1st Moscow State Medical University Moscow Russian Federation

Institute of Applied Health Sciences University of Aberdeen Aberdeen UK

School of Physics Engineering and Computer Science University of Hertfordshire Hatfield UK

UOC Ginecologia Oncologica Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica Policlinico Agostino Gemelli IRCCS Rome Italy

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International Variations in Surgical Morbidity and Mortality Post Gynaecological Oncology Surgery: A Global Gynaecological Oncology Surgical Outcomes Collaborative Led Study (GO SOAR1)

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ClinicalTrials.gov
NCT04579861