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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)

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Clinical trial
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)
  1. Faiza Gaba1,2,
  2. Nicolò Bizzarri3,
  3. Paul Kamfwa4,
  4. Allison Saiz5,
  5. Oleg Blyuss6,7,
  6. Shantini Paranjothy8,
  7. Pedro T Ramirez9 and
  8. David Cibula10
  9. on behalf of the GO SOAR Team
    1. 1 Department of Gynaecological Oncology, North-East of Scotland Gynaecological Oncology Centre, Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK
    2. 2 Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
    3. 3 UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Policlinico Agostino Gemelli IRCCS, Rome, Italy
    4. 4 Department of Gynaecological Oncology, Cancer Diseases Hospital, Lusaka, Zambia
    5. 5 Department of Gynecologic Oncology, Northwestern University in Chicago, Evanston, Illinois, USA
    6. 6 School of Physics, Engineering & Computer Science, University of Hertfordshire, Hatfield, UK
    7. 7 Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child’s Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation
    8. 8 Aberdeen Health Data Science Research Centre, University of Aberdeen, Aberdeen, UK
    9. 9 Department of Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, Texas, USA
    10. 10 Department of Obstetrics and Gynaecology, General University Hospital, Prague, Czech Republic
    1. Correspondence to Dr Faiza Gaba, Department of Gynaecological Oncology, North-East of Scotland Gynaecological Oncology Centre, Aberdeen Royal Infirmary, NHS Grampian, Aberdeen AB15 6RE, UK; faiza.gaba1{at}abdn.ac.uk

    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).

    • surgical oncology
    • gynecologic surgical procedures
    • postoperative complications

    Data availability statement

    There are no data in this work.

    https://doi.org/10.1136/ijgc-2021-002586

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      Data availability statement

      There are no data in this work.

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      Footnotes

      • Twitter @FaizaGaba, @pedroramirezMD

      • Collaborators on behalf of the GO SOAR Team: Mohamedraed Elshami, Mahmoud Saad, Ahmed Nafea, Muhammed Elhadi, Alaa Ismail, Hamza Al-Naggar, Darin Maria Cecilia, Maximilian Lanner, Andrei Pletnev, Basel Refky, Abdelazez Elkady, Tarek Karkour, Hazim Salah Ali, Sherief Ghozy, Sameh Daghash, Mohamed Hamed Elmelegy, Eman Monier, Mohammad Abdel-Rahman Mohammad, Domenico Ferraioli, Tanja Nikolova, Stamatios Petousis, Charalampos Theofanakis, Jagannth Mishra, Vadaparty Annapurna, Mariam Anjum Ifthikar, Anik Ghosh, Ajay Chanakya Vallabhaneni, Bijoy Kar, Alyaa Al-khafaji, Ali Al-Isawi, Michael O’Leary, Fabio Martinelli, Martina Arcieri, Stefano Restaino, Anna Fagotti, Edoardo Cola, Stefano Bogliolo, Qais Shatnawi, Amer Mahmoud Sindiani, Wafa Alsardieh, Abdulrahman Qasem, Shatha Husain, Maherah Kamarudin, Moniba Korch, Ishak Lawal, Adeyemi Okunowo, Mohammed Alkronz, Khalil Abuzaina, Farah Shahin, Waleed Abu Hatab, Najib Salameh, Mohammed Awad, Adnan Radi, João Casanova, Kamil Zalewski, Amel Yousif, Igor Govorov, Ahmed Abu-Zaid, Susan Alghamdi, Antonio Gil Moreno, Natalia Rodriguez, Felix Boria, Zoia Razumova, Zuheir Alshehabi, Bassam Hassan, Hamdi Nawfal, Amr Hamza, Seda Şahin Aker, Salih Taskin, Ilker Kahramanoglu, Ilker Selcuk, Mahalakshmi Gurumurthy, Mary Cairns, Lori McPherson, Sadaf Ghaem-Maghami, John Butler, Christine Ang, Aarti Sharma, Hamza Al-Naggar, Sara Saif, Swali V Fundafunda, Lina Karout, Mohamad B Kassab, Ali Safar, Reem Abdallah, Sana Hatoum, Said Mohamad Elmakkaoui, Rania Itani, Jihad El Hassan, Samar Karout, Hussein Mansour Jamal Eddine, David Atallah, Aya Zazo, Noor Abualdahab, Shohra Qaderi, Salah Eddine Oussama Kacimi, Mustafa Mohamed, Hanan Haidar, Chee Yang Tan, Wafaa Shehada, Hisham Ahmed Abou-Taleb, Mohamed O. Herdan, Ali Hussien Ali, Ahmed Ragab Ali Ahmed, Omar Salah Ibrahim Mohamed, Mohamed I Omar, Eman Ibrahim Zineldin, Ahmed Sabry Fouad El-hamouly, Baraa N. Hajjaj, Shukri Odeh Yousef, Besan Shaheen, Akram Elhossini, Ziena Obiedat, Maen Alsumadi, Victor Lago, Amani Alsattari, Ayat Aljuba, Bisan Ahmed, Salsabeel Abed, Akram Husaini, Subhi Maher Abusharkh, Martina Aida Angeles.

      • Contributors Contribution to authorship. Collaborative conception and design: FG. Study conception and design: FG. Protocol development: FG, DC, NB, PTR, PK, AS, SP, OB. Database development: FG, NB, PK, AS, SP, OB, DC. Steering committee: FG, DC, PTR, NB, PK, AS, SP, OB. Study management: FG, NB, PK, AS, SP, OB. Preparation of figure: FG. Initial draft of manuscript: FG. Statistical aspects: FG, OB. Manuscript writing and approval: All authors.

      • Funding The NHS Grampian Endowment Fund; Medtronic; Karl Storz.

      • Competing interests FG declares funding from The NHS Grampian Endowment Fund, Medtronic, Karl Storz for the GO SOAR1 study and is Chief Investigator.

      • Provenance and peer review Not commissioned; externally peer reviewed.