Hospital Universitario Mayor - Méderi, Bogotá, Colombia
Universidad del Rosario, Bogotá, Colombia.
BMJ Open. 2024 Nov 1;14(10):e086655. doi: 10.1136/bmjopen-2024-086655.
Bile fluid is aseptic under normal conditions; however, in the presence of cholecystitis, its susceptibility to bacterial colonisation varies, with reported rates of 20%-70% of cases. This process is referred to as bactibilia and/or bacteriobilia and can be considered a secondary complication of biliary stasis and cholecystitis in general. In the management of acute cholecystitis, the antibiotic regimen should be prescribed based on the presumed pathogens involved, taking into consideration the risk factors for resistance patterns according to demographics and local exposure. The aim of this study is to determine the predictive factors for bile culture positivity and antibiotic resistance in patients who underwent laparoscopic cholecystectomy in the Méderi Hospital Network. We hope to develop a predictive model that allows us to better guide antibiotic therapy.
This is a prospective observational cohort study with prognostic prediction model. Patients who will undergo laparoscopic cholecystectomy and have bile cultures taken in the Méderi Hospital Network during the study period will be included. The dependent variables will be positive bile culture and antibiotic resistance, and the predictive variables will be age, presence of diabetes, diagnosis of choledocholithiasis, diagnosis of cholecystitis and severity of cholecystitis according to the Tokyo criteria. The minimum sample size has been calculated at 703 patients. Follow-up will continue until a control appointment 15 days after the procedure. The primary outcomes are bile culture positivity and phenotypical antibiogram resistance. For each outcome, a multivariate logistic regression will be performed using frequentist and Bayesian prediction techniques.
This study was approved by the Méderi network research department committee (CIMED) and by Universidad del Rosario's Research Ethics Committee (CEI-UR; DVO005 2555-CV1837). Written informed consent is required for participation. The results will be disseminated through the submission of an academic article to a high-impact scientific journal, presentations at academic conferences, and sharing with our institution's faculty to inform antimicrobial therapy management based on local epidemiological data.
NCT06314399.
在正常情况下，胆汁是无菌的；然而，在胆囊炎的情况下，其对细菌定植的易感性有所不同，报告的病例发生率为 20%-70%。这个过程被称为胆汁菌血症和/或菌血症，可以被认为是一般胆道淤滞和胆囊炎的继发并发症。在急性胆囊炎的治疗中，应根据所涉及的假定病原体开具抗生素方案，同时考虑根据人口统计学和局部暴露情况预测耐药模式的危险因素。本研究的目的是确定在梅德里医院网络中接受腹腔镜胆囊切除术的患者胆汁培养阳性和抗生素耐药的预测因素。我们希望开发一个预测模型，以更好地指导抗生素治疗。
这是一项具有预后预测模型的前瞻性观察性队列研究。研究期间将纳入在梅德里医院网络中接受腹腔镜胆囊切除术且进行胆汁培养的患者。因变量将是胆汁培养阳性和抗生素耐药性，预测变量将是年龄、是否存在糖尿病、胆总管结石诊断、胆囊炎诊断和根据东京标准的胆囊炎严重程度。最小样本量计算为 703 例患者。随访将持续到手术后 15 天的控制预约。主要结局是胆汁培养阳性和表型抗生素耐药性。对于每个结局，将使用频率论和贝叶斯预测技术进行多变量逻辑回归。
本研究得到了梅德里网络研究部门委员会（CIMED）和罗萨里奥大学研究伦理委员会（CEI-UR；DVO005 2555-CV1837）的批准。需要书面知情同意才能参与。研究结果将通过向高影响力科学期刊提交学术文章、在学术会议上发表演讲以及与我们机构的教员分享来传播，以根据当地的流行病学数据来指导抗生素治疗管理。
NCT06314399。
