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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)

F. Gaba, N. Bizzarri, P. Kamfwa, A. Saiz, O. Blyuss, S. Paranjothy, PT. Ramirez, D. Cibula, GO SOAR Team

. 2021 ; 31 (9) : 1287-1291. [pub] -

Jazyk angličtina Země Velká Británie

Typ dokumentu časopisecké články, multicentrická studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc22012246
E-zdroje Online Plný text

NLK ProQuest Central od 2018-01-01 do Před 6 měsíci
Health & Medicine (ProQuest) od 2018-01-01 do Před 6 měsíci

Odkazy

PubMed 34489356
DOI 10.1136/ijgc-2021-002586
Knihovny.cz E-zdroje

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).

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