Predictive Factors Associated with Bile Culture Positivity and PhenotypiCal AntIbiogram Resistance Patterns in Patients Taken to LaparOscopic Cholecystectomy (BACILO): a Protocol for a Prediction Model Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 703
- 试验地点
- 2
- 主要终点
- Phenotypical antibiogram resistance
研究概览
简要总结
The BACILO study was designed with the objective of having robust data on local epidemiological bacterial colonisation information on bile cultures with patients taken to laparoscopic cholecystectomy in our institution to find which predictive factors are associated with culture positivity and antibiotic resistance patterns. Secondary endpoints include evaluating demographical, clinical and surgical variables and establishing comparison between both positive and negative bile cultures and between antibiotic sensitive and resistant microorganism strain isolations.
详细描述
BACILO is single-centre, observational, analytical, prospective study with a prognostic prediction model with the objective of identifying predictive factors associated with microbial and antibiotic resistance patterns in bile cultures of patients taken to laparoscopic cholecystectomy in our institution. Primary outcomes are bile culture positivity and phenotypical resistance antibiogram patterns while secondary outcomes include demographic, clinical and surgical characteristics and surgical outcomes. The main objective is to determine predictive factors using a prediction model, variables included are: Age, diabetes mellitus, C-reactive protein test, choledocholithiasis/ERCP, cholecystitis and severity of cholecystitis according to the 2018 Tokyo guidelines.This in the nature of describing the relationship between bile culture positivity and phenotypical antibiogram resistance patterns in our institution, and establish thus better treatment strategies based on higher quality local evidence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included must be over 18 years of age and be taken to laparoscopic cholecystectomy between March 2024 and February 2026 in any institution of the Méderi hospital network (Hospital Universitario Mayor and Hospital Universitario Barrios Unidos), have signed the written informed consent to be included in the study and have both bile culture and antibiogram.
排除标准
- •- Patients that will be taken to laparoscopic cholecystectomy with another concomitant surgical procedure (including but not exclusive to gastrectomy, pancreatoduodenectomy, oesophagectomy, splenectomy, abdominal wall reconstruction, colectomy, amongst others) with the exception of umbilical herniorrhaphy.
- •Patients without a postoperative control appointment.
- •Patients with an untreated HIV diagnosis.
- •Patients with diagnosis of a malignant gallbladder or biliary tract disease documented preoperatively.
结局指标
主要结局
Phenotypical antibiogram resistance
时间窗: Perioperatively, during the procedure and immediately after the intervention
If bile culture is positive, evaluation for possible antibiotic resistance vs sensitivity
Bile culture positivity
时间窗: Perioperatively, during the procedure and immediately after the intervention
Bile culture is tested positive for at least one (1) microorganism
次要结局
- Bile culture and antibiotic resistance relationship(Immediately after the intervention)
- Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis)(Through study completion, around 1 year and a half)
- Demographical and clinical characteristics(Pre-intervention)
- Microbial characteristics(Immediately after the intervention)
- Surgical characteristics and outcomes(During the 15 day postoperative follow-up appointment)
研究者
Camilo Ramirez Giraldo
Principal Investigator - General Surgeon
Hospital Universitario Mayor Méderi