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, 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.
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.
| Original language | English |
|---|---|
| Pages (from-to) | 1287-1291 |
| Number of pages | 5 |
| Journal | International Journal of Gynecological Cancer |
| Volume | 31 |
| Issue number | 9 |
| Early online date | 6 Sep 2021 |
| DOIs | |
| Publication status | Published - 6 Sep 2021 |
Access to Document
- Gaba_etal_IJGC_determining_post-operative_morbidity_AAM
https://creativecommons.org/licenses/by-nc/4.0/ this is the accepted unformatted version of Gaba F, Bizzarri N, Kamfwa P on behalf of the GO SOAR Team, et al Determining post-operative morbidity and mortality following gynecological oncology surgery: protocol for a multicenter, international, prospective cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative—GO SOAR) International Journal of Gynecologic Cancer 2021;31:1287-1291.
- Gaba_etal_Figure_v1
https://creativecommons.org/licenses/by-nc/4.0/