List of Publications by Department for the Academic Year Determining post-operative morbidity and mortality following gynecological oncology surgery: protocol for a multi-center, international, prospective cohort study (Global Gynecological Oncology Surgical Outcomes Collaborative—GO SOAR)
Abstract
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, multi-center, 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).
Journal/Conference Information
International Journal of Gynecological Cancer. BMJ,DOI: 10.1136/ijgc-2021-002586, ISSN: 1525-1438, Volume: 31, Issue: 9, Pages Range: 1287-1291,