Correlation between stone culture and infective complications of PCNL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Correlation between stone culture and infective complications of PCNL.
研究概览
简要总结
Urosepsis in post-operative period may prove to be catastrophic despite adequate pre-operative antibiotic coverage, and negative urine culture. Culture of the stone could thus be used as an early guide for treatment or prevention of post-operative urosepsis. Stone culture is not a usual practice in endourologic surgeries, and pre-operative urine cultures have been heavily relied on for treatment of post-operative infections and sepsis. The aim of this study was to find correlation between intra-operative stone culture obtained during PCNL with pre-operative urine culture and its correlation with infective complications related to the procedure.
Primary Objective - To assess the correlation between stone culture and infective complications of PCNL.
Justification for study : The high rates of post-PCNL infective complications warrant the need for well-defined predictive factors and high index of suspicion in the prediction of such complications. Stone culture will help in predicting infective complications in PCNL and help in administering appropriate intervention.
Benefits of the study:
In determining the role of stone culture in predicting infective complications of PCNL so as to administer timely intervention.
To assess the stone culture sensitivity in local population so that any changes if required can be implemented in the current antibiotic protocol in our department.
Ethical considerations: Institutional Ethics Committee clearance obtained. Consent forms will be obtained from the patient if they are willing to participate in the study. Confidentiality will be maintained as identities of participants will not be revealed and only their hospital ID numbers will be used for reference in the study.
Study Hypothesis - There is positive correlation between stone culture and occurrence of postoperative infective complications of PCNL.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients undergoing PCNL.
- •Patients treated for prior stone related uro-sepsis.
- •Presence of indwelling DJ stent/ catheter or PCN (Subset – To assess their microbial characteristics).
排除标准
- •As it is only an observational study, no exclusion criteria is being applied.
结局指标
主要结局
Correlation between stone culture and infective complications of PCNL.
时间窗: Baseline, POD-0,POD-1 and at 4 weeks.
次要结局
- Correlation between stone culture & renal function.(Correlation between stone culture & pre-operative urine culture in all patients included in the study.)
研究者
Krishnakanth AVB
Kasturba Medical College and Hospital
