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).
gynecologic surgical procedures
postoperative complications
surgical oncology
Journal
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
ISSN: 1525-1438
Titre abrégé: Int J Gynecol Cancer
Pays: England
ID NLM: 9111626
Informations de publication
Date de publication:
09 2021
09 2021
Historique:
accepted:
12
04
2021
entrez:
7
9
2021
pubmed:
8
9
2021
medline:
29
1
2022
Statut:
ppublish
Résumé
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. 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. 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. 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. 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. 30-day post-operative morbidity and mortality defined as per Clavien-Dindo classification system. 1100 (550/arm). It is estimated recruitment will be completed by 2022 and results published by 2023. ClinicalTrials.gov registry: NCT04579861 (https://clinicaltrials.gov/ct2/show/NCT04579861).
Sections du résumé
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).
Identifiants
pubmed: 34489356
pii: ijgc-2021-002586
doi: 10.1136/ijgc-2021-002586
doi:
Banques de données
ClinicalTrials.gov
['NCT04579861']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1287-1291Investigateurs
Mohamedraed Elshami
(M)
Mahmoud Saad
(M)
Ahmed Nafea
(A)
Muhammed Elhadi
(M)
Alaa Ismail
(A)
Hamza Al-Naggar
(H)
Darin Maria Cecilia
(DM)
Maximilian Lanner
(M)
Andrei Pletnev
(A)
Basel Refky
(B)
Abdelazez Elkady
(A)
Tarek Karkour
(T)
Hazim Salah Ali
(HS)
Sherief Ghozy
(S)
Sameh Daghash
(S)
Mohamed Hamed Elmelegy
(MH)
Eman Monier
(E)
Mohammad Abdel-Rahman Mohammad
(MA)
Domenico Ferraioli
(D)
Tanja Nikolova
(T)
Stamatios Petousis
(S)
Charalampos Theofanakis
(C)
Jagannth Mishra
(J)
Vadaparty Annapurna
(V)
Mariam Anjum Ifthikar
(MA)
Anik Ghosh
(A)
Ajay Chanakya Vallabhaneni
(AC)
Bijoy Kar
(B)
Alyaa Al-Khafaji
(A)
Ali Al-Isawi
(A)
Michael O'Leary
(M)
Fabio Martinelli
(F)
Martina Arcieri
(M)
Stefano Restaino
(S)
Anna Fagotti
(A)
Edoardo Cola
(E)
Stefano Bogliolo
(S)
Qais Shatnawi
(Q)
Aya Zazo
(A)
Amer Mahmoud Sindiani
(AM)
Wafa Alsardieh
(W)
Abdulrahman Qasem
(A)
Shatha Husain
(S)
Maherah Kamarudin
(M)
Moniba Korch
(M)
Ishak Lawal
(I)
Adeyemi Okunowo
(A)
Mohammed Alkronz
(M)
Victor Lago
(V)
Amani Alsattari
(A)
Khalil Abuzaina
(K)
Farah Shahin
(F)
Ayat Aljuba
(A)
Waleed Abu Hatab
(WA)
Najib Salameh
(N)
Adnan Radi
(A)
João Casanova
(J)
Kamil Zalewski
(K)
Amel Yousif
(A)
Igor Govorov
(I)
Ahmed Abu-Zaid
(A)
Susan Alghamdi
(S)
Antonio Gil Moreno
(AG)
Natalia Rodriguez
(N)
Felix Boria
(F)
Zoia Razumova
(Z)
Zuheir Alshehabi
(Z)
Bassam Hassan
(B)
Hamdi Nawfal
(H)
Amr Hamza
(A)
Seda Şahin Aker
(SŞ)
Salih Taskin
(S)
Ilker Kahramanoglu
(I)
Ilker Selcuk
(I)
Mahalakshmi Gurumurthy
(M)
Mary Cairns
(M)
Lori McPherson
(L)
Sadaf Ghaem-Maghami
(S)
John Butler
(J)
Christine Ang
(C)
Aarti Sharma
(A)
Hamza Al-Naggar
(H)
Sara Saif
(S)
Noor Abualdahab
(N)
Shohra Qaderi
(S)
Swali V Fundafunda
(SV)
Mohammed Awad
(M)
Lina Karout
(L)
Mohamad B Kassab
(MB)
Ali Safar
(A)
Reem Abdallah
(R)
Sana Hatoum
(S)
Said Mohamad Elmakkaoui
(SM)
Rania Itani
(R)
Jihad El Hassan
(J)
Samar Karout
(S)
Hussein Mansour Jamal Edine
(HMJ)
David Atallah
(D)
Salah Eddine Oussama Kacimi
(SEO)
Mustafa Mohamed
(M)
Chee Yang Tan
(CY)
Hanan Haidar
(H)
Wafaa Shehada
(W)
Hisham Ahmed Abou-Taleb
(HA)
Mohamed O Herdan
(MO)
Ali Hussien Ali
(AH)
Ahmed Ragab Ali Ahmed
(ARA)
Omar Salah Ibrahim Mohamed
(OSI)
Mohamed I Omar
(MI)
Eman Ibrahim Zineldin
(EI)
Ahmed Sabry Fouad El-Hamouly
(ASF)
Baraa N Hajjaj
(BN)
Shukri Odeh Yousef
(SO)
Besan Shaheen
(B)
Akram Elhossini
(A)
Ziena Obiedat
(Z)
Maen Alsumadi
(M)
Bisan Ahmed
(B)
Salsabeel Abed
(S)
Akram Husaini
(A)
Subhi Maher Abusharkh
(SM)
Martina Aida Angeles
(MA)
Informations de copyright
© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: FG declares funding from The NHS Grampian Endowment Fund, Medtronic, Karl Storz for the GO SOAR1 study and is Chief Investigator.