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). Issue 9 (September 2021)

• Record Type: Journal Article
• Authors: Gaba, Faiza; Bizzarri, Nicolò; Kamfwa, Paul; Saiz, Allison; Blyuss, Oleg; Paranjothy, Shantini; Ramirez, Pedro T; Cibula, David; Elshami, Mohamedraed; Saad, Mahmoud; Nafea, Ahmed; Elhadi, Muhammed; Ismail, Alaa; Al-Naggar, Hamza; Cecilia, Darin Maria; Lanner, Maximilian; Pletnev, Andrei; Refky, Basel; Elkady, Abdelazez; Karkour, Tarek; Ali, Hazim Salah; Ghozy, Sherief; Daghash, Sameh; Elmelegy, Mohamed Hamed; Monier, Eman; Mohammad, Mohammad Abdel-Rahman; Ferraioli, Domenico; Nikolova, Tanja; Petousis, Stamatios; Theofanakis, Charalampos; Mishra, Jagannth; Annapurna, Vadaparty; Ifthikar, Mariam Anjum; Ghosh, Anik; Vallabhaneni, Ajay Chanakya; Kar, Bijoy; Al-khafaji, Alyaa; Al-Isawi, Ali; O'Leary, Michael; Martinelli, Fabio; Arcieri, Martina; Restaino, Stefano; Fagotti, Anna; Cola, Edoardo; Bogliolo, Stefano; Shatnawi, Qais; Zazo, Aya; Sindiani, Amer Mahmoud; Alsardieh, Wafa; Qasem, Abdulrahman; Husain, Shatha; Kamarudin, Maherah; Korch, Moniba; Lawal, Ishak; Okunowo, Adeyemi; Alkronz, Mohammed; Lago, Victor; Alsattari, Amani; Abuzaina, Khalil; Shahin, Farah; Aljuba, Ayat; Hatab, Waleed Abu; Salameh, Najib; Radi, Adnan; Casanova, João; Zalewski, Kamil; Yousif, Amel; Govorov, Igor; Abu-Zaid, Ahmed; Alghamdi, Susan; Moreno, Antonio Gil; Rodriguez, Natalia; Boria, Felix; Razumova, Zoia; Alshehabi, Zuheir; Hassan, Bassam; Nawfal, Hamdi; Hamza, Amr; Aker, Seda Şahin; Taskin, Salih; Kahramanoglu, Ilker; Selcuk, Ilker; Gurumurthy, Mahalakshmi; Cairns, Mary; McPherson, Lori; Ghaem-Maghami, Sadaf; Butler, John; Ang, Christine; Sharma, Aarti; Al-Naggar, Hamza; Saif, Sara; Abualdahab, Noor; Qaderi, Shohra; Fundafunda, Swali V; Awad, Mohammed; Karout, Lina; Kassab, Mohamad B; Safar, Ali; Abdallah, Reem; Hatoum, Sana; Elmakkaoui, Said Mohamad; Itani, Rania; El Hassan, Jihad; Karout, Samar; Edine, Hussein Mansour Jamal; Atallah, David; Kacimi, Salah Eddine Oussama; Mohamed, Mustafa; Tan, Chee Yang; Haidar, Hanan; Shehada, Wafaa; Abou-Taleb, Hisham Ahmed; Herdan, Mohamed O.; Ali, Ali Hussien; Ahmed, Ahmed Ragab Ali; Mohamed, Omar Salah Ibrahim; Omar, Mohamed I; Zineldin, Eman Ibrahim; El-hamouly, Ahmed Sabry Fouad; Hajjaj, Baraa N.; Yousef, Shukri Odeh; Shaheen, Besan; Elhossini, Akram; Obiedat, Ziena; Alsumadi, Maen; Ahmed, Bisan; Abed, Salsabeel; Husaini, Akram; Abusharkh, Subhi Maher; Angeles, Martina Aida;
• Is Part Of: International journal of gynecological cancer. Volume 31:Issue 9(2021)
• Publication Date: 2021-09
• Subjects: surgical oncology -- gynecologic surgical procedures -- postoperative complications; Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1136/ijgc-2021-002586
• Languages: English
• ISSNs: 1048-891X

Abstract

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. Trial Registration: ClinicalTrials.gov registry: NCT04579861 (https://clinicaltrials.gov/ct2/show/NCT04579861 ).