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).
Int J Gynecol Cancer
; 31(9): 1287-1291, 2021 09.
Article
em En
| MEDLINE
| ID: mdl-34489356
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. PRIMARYOBJECTIVE:
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. STUDYDESIGN:
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 PRESENTINGRESULTS:
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).Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Procedimentos Cirúrgicos em Ginecologia
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Neoplasias dos Genitais Femininos
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Guideline
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Incidence_studies
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Observational_studies
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Risk_factors_studies
Limite:
Female
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Humans
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article