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  • Global evaluation and outcomes of cholecystectomy: protocol for a multicentre, international, prospective cohort study (GlobalSurg 4)

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Global health
Protocol
Global evaluation and outcomes of cholecystectomy: protocol for a multicentre, international, prospective cohort study (GlobalSurg 4)
  1. Ewen Harrison1,
  2. Sivesh Kathir Kamarajah2
  3. NIHR Global Health Research Unit on Global Surgery
    1. 1University of Edinburgh Western General Hospital, Edinburgh, UK
    2. 2NIHR Global Health Research Unit on Global Surgery, Institute of Applied Health Research, Birmingham, UK
    3. 3NIHR Unit on Global Surgery (Universities of Birmingham, Edinburgh and Warwick), University of Edinburgh Western General Hospital, Edinburgh, UK
    1. Correspondence to Prof Ewen Harrison; ewen.harrison{at}ed.ac.uk; Dr Sivesh Kathir Kamarajah; s.k.kamarajah{at}bham.ac.uk

    Abstract

    Introduction Cholecystectomy is one of the most common operations performed worldwide. Although laparoscopic surgery has been the ‘gold-standard’ approach for this operation, there is a paucity of global evidence around the variations of safe provision of cholecystectomy, including low-income and middle-income countries. This international collaborative study will allow contemporaneous data collection on the quality of cholecystectomies using measures covering infrastructure, care processes and outcomes, with the primary aim define the global variation in compliance with preoperative, intraoperative and postoperative audit standards.

    Methods and analysis Global Evaluation of Cholecystectomy Knowledge and Outcomes is a prospective, international, multicentre, observational cohort study delivered by the GlobalSurg Collaborative. Consecutive patients undergoing cholecystectomy between 31 July 2023 and 19 November 2023 will be recruited, with follow-up at 30 days and 1-year postoperatively. The study will be undertaken at any hospital providing emergency or elective surgical services for biliary disease. The primary endpoint of this study is compliance with preoperative, intraoperative and postoperative audit standards. Secondary outcomes include rates of 30-day complications, achievement of critical view of safety and rates of gallbladder cancer.

    Ethics and dissemination This project will not affect clinical practice and has been classified as clinical audit following research ethics review at University Hospital Birmingham NHS Trust. The protocol will be disseminated through the international GlobalSurg and CovidSurg network.

    Trial registration number NCT06223061.

    • SURGERY
    • Hepatobiliary disease
    • Health Services Accessibility
    http://creativecommons.org/licenses/by-nc/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

    https://doi.org/10.1136/bmjopen-2023-079599

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      Footnotes

      • X @Sivesh93

      • Collaborators Sivesh K Kamarajah*, Omar Kouli*, Philip Alexander, Nicolas Avellaneda, Malcolm Cameron, Amanda Dawson, Alex Dermanis, Dhruv Ghosh, Ewen Griffiths, Rachel Guest, Parvez Haque, Laura Kehoe, Souliath Lawani, Janet Martin, Antonio Ramos-De la Medina, Ana Minaya Bravo, Dion G Morton, Riinu Pius, John Primrose, Keith Roberts, Ajith Siriwardena, Sohei Satoi, Catherine Shaw, Robert Sutcliffe, Ng Wee Han, Ewen M Harrison.

      • Contributors All authors within the NIHR Global Health Group on Global Surgery contributed to the design, drafting and review of this study protocol. In addition to this, SKK and EH is the overall guarantor for this article.

      • Funding This study is funded by the NIHR Global Health Research Unit on Global Surgery (NIHR16.136.79).

      • Competing interests GlobalSurg is run by the Surgical Research Gateway (SuRG) Foundation. The SuRG Foundation is a registered charity (charity number 1159898) whose object is to advance the education of medical students and doctors in surgical science, clinical research by promoting participation in collaborative clinical research and audit studies.

      • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

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

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.