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985 Post-Operative Morbidity & Mortality following Gynaecological Oncology Surgery: Protocol for a Global Prospective Cohort Study (GO SOAR1)
  1. F Gaba1;2,
  2. N Bizzarri3,
  3. P Kamfwa4,
  4. A Saiz5,
  5. O Blyuss6,
  6. S Paranjothy2,
  7. P Ramirez7 and
  8. D Cibula8
  1. 1Aberdeen Royal Infirmary
  2. 2University of Aberdeen, UK
  3. 3Fondazione Policlinico Universitario A. Gemelli, IRCCS, Italy
  4. 4Cancer Diseases Hospital, Zambia
  5. 5Northwestern University in Chicago, USA
  6. 6University of Hertfordshire, UK
  7. 7MD Anderson Cancer Center, USA
  8. 8Charles University and General University Hospital, Czech Republic


Introduction/Background*The Global Gynaecological Oncology Surgical Outcomes Collaborative aims to develop a network of gynaecological oncology surgeons, surgical departments and other interested parties that will have the long-term ability to collaborate on outcome studies. Presented is the protocol for the first collaborative study. Our primary objective is to evaluate international variation in thirty day post-operative morbidity and mortality following gynaecological oncology surgery between very high/high and medium/low human development index country settings.

Design International, multi-centre, prospective, observational, cohort-study. Two study-arms: very high/high and medium/low human development index (HDI) country settings. registry: NCT04579861.

Inclusion criteria 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.

Exclusion criteria Non-gynaecological disease as the primary malignancy, diagnostic procedures, or any procedure not requiring a skin incision under general/regional anaesthesia.

Recruitment Patient data will be collected over a consecutive thirty day period through Gynaecological Oncology multidisciplinary teams and clinics across different HDI country groups. All data is collected on a customised, secure, password protected, central REDCap database.

Primary outcome Thirty day post-operative morbidity and mortality defined as per Clavien Dindo classification system.

Secondary outcomes Intra-operative morbidity/mortality; rate of tumour clearance; international prospective surgical outcomes database; comparison of current practice against selected tumour specific audit standards derived from the European Society of Gynaecological Oncology guidelines.

Sample size 1100 (550/arm) inflated by 20% to account for missing data and loss to follow up, at 90% power, α=0.05, will be able to determine a 10% point difference in thirty day post-operative morbidity and mortality following Gynaecological Oncology surgery between high/high and medium/low HDI country settings

Result(s)*GO SOAR1 is open to recruitment internationally.

Conclusion*The GO SOAR Collaborative aims to improve surgical outcomes through collaborative research. It will provide risk adjusted patient level outcome data collected via a centralised database to advise HDI country group specific policy formation.

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