Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction. A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Urinary Tract Infection After Percutaneous Nephrostomy Procedure
研究概览
简要总结
This study aims to find out whether taking antibiotics to prevent a urinary tract infection after a medical procedure called percutaneous nephrostomy (placement of a catheter directly into the kidney to keep it working after the urinary tract has been blocked by a malignant tumour) actually prevents a urinary tract infection, compared to not taking antibiotic prophylaxis.
详细描述
The medical records of cancer patients who underwent percutaneous nephrostomy between January 2013 and July 2020 were reviewed. Procedures were excluded if the nephrostomy was used for other procedures (e.g. double-J passage) or for non-malignant urinary tract obstruction (e.g. kidney stones). The association between antibiotic prophylaxis and UTI was assessed using association tests such as Pearson's chi-squared or Fisher's exact test. A significant level of 5% was adopted.
Definitions:
Urinary tract infection - occurs when there are signs and symptoms consistent with a local infection (fever, chills, dysuria, lower back pain, and costovertebral angle tenderness), such as cystitis (bladder or lower UTI) or pyelonephritis (kidney or upper UTI), combined with a positive urine culture (more than 104 colony-forming units of microorganisms per millilitre of urine with a catheter present or more than 105 colony-forming units of microorganisms per millilitre of urine without a catheter present).
UTI related to percutaneous nephrostomy procedure - occurs until seven days after the percutaneous nephrostomy procedure, both for first placement and/or catheter replacement.
UTI related to the nephrostomy catheter - occurs at another time, usually within 90 days of the procedure, in the presence of the nephrostomy catheter, and in the absence of another focus that would justify the infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated for cancer who required percutaneous nephrostomies
排除标准
- •Patients and/or procedures if percutaneous nephrostomy was used to perform other procedures;
- •Patients and/or procedures if percutaneous nephrostomy was used to treat clinical conditions other than malignant ureteral obstruction
- •Patients and/or procedures if percutaneous nephrostomy was used to clear the urinary tract of non-malignant causes
研究组 & 干预措施
Antibiotic prophylaxis (AP) - Group
With antibiotic prophylaxis before percutaneous nephrostomy
干预措施: antibiotic prophylaxis (Drug)
No antibiotic prophylaxis (NAP) - Group
No antibiotic prophylaxis before percutaneous nephrostomy
结局指标
主要结局
Urinary Tract Infection After Percutaneous Nephrostomy Procedure
时间窗: Up to 7 days after percutaneous nephrostomy
Proportion of urinary tract infection after each percutaneous nephrostomy
次要结局
未报告次要终点
研究者
Jeferson Rodrigo Zanon
Principal Investigator
Barretos Cancer Hospital
