University of Edinburgh Western General Hospital, Edinburgh, UK
NIHR Global Health Research Unit on Global Surgery, Institute of Applied Health Research, Birmingham, UK
BMJ Open. 2024 Jul 25;14(7):e079599. doi: 10.1136/bmjopen-2023-079599.
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.
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.
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.
NCT06223061.
胆囊切除术是全球最常见的手术之一。尽管腹腔镜手术已成为该手术的“金标准”方法，但关于胆囊切除术安全提供的变化，包括低收入和中等收入国家，全球证据有限。这项国际合作研究将允许同时收集有关胆囊切除术质量的当代数据，这些数据涵盖基础设施、护理流程和结果，主要目的是确定术前、术中、术后审计标准的全球差异。
全球胆囊切除术知识和结果评估是由 GlobalSurg 合作组织进行的一项前瞻性、国际、多中心、观察性队列研究。在 2023 年 7 月 31 日至 2023 年 11 月 19 日期间，将招募连续接受胆囊切除术的患者，术后 30 天和 1 年进行随访。该研究将在任何提供胆道疾病急诊或择期手术服务的医院进行。本研究的主要终点是遵守术前、术中、术后审计标准。次要结局包括 30 天并发症发生率、实现安全关键视图的比例和胆囊癌发生率。
该项目不会影响临床实践，并在伯明翰大学医院 NHS 信托基金的研究伦理审查后被归类为临床审计。该方案将通过国际 GlobalSurg 和 CovidSurg 网络传播。
NCT06223061。
