University of Birmingham, Birmingham, UK.
BMJ Open. 2017 Jul 21;7(7):e012150. doi: 10.1136/bmjopen-2016-012150.
Surgical site infection (SSI) is the most common complication following major gastrointestinal surgery, affecting between 25% and 40% of patients. The rate of SSI doubles from low-income to high-income settings, persisting after risk adjustment. The relative impact of antibiotic-resistant organisms and the effectiveness of antibiotic prophylaxis globally are unknown. This study aims to determine SSI rates following gastrointestinal surgery across worldwide hospital settings.
This multicentre, international, prospective cohort study will be undertaken by any hospital providing emergency or elective gastroenterological surgical services. Centres will collect observational data on consecutive patients undergoing emergency or elective gastrointestinal resection, cholecystectomy or appendicectomy during a 6-month period. The primary outcome is the incidence of SSI with secondary outcomes describing the organisms causing SSIs, including their antibiotic susceptibility, and the microbiological tests used to identify them.
This project will not affect clinical practice and has been classified as clinical audit following research ethics review. The protocol will be disseminated through the international GlobalSurg network.
NCT02662231.
手术部位感染(SSI)是大型胃肠道手术后最常见的并发症,影响25%至40%的患者。从低收入地区到高收入地区,SSI的发生率翻倍,在风险调整后仍然存在。全球范围内,耐药生物体的相对影响以及抗生素预防的有效性尚不清楚。本研究旨在确定全球医院环境下胃肠道手术后的SSI发生率。
这项多中心、国际性、前瞻性队列研究将由任何提供急诊或择期胃肠外科手术服务的医院进行。各中心将收集在6个月期间接受急诊或择期胃肠道切除术、胆囊切除术或阑尾切除术的连续患者的观察数据。主要结局是SSI的发生率,次要结局描述导致SSI的生物体,包括它们的抗生素敏感性以及用于识别它们的微生物学检测。
本项目不会影响临床实践,在经过研究伦理审查后已被归类为临床审计。该方案将通过国际GlobalSurg网络进行传播。
NCT02662231。