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临床试验/NCT06801405
NCT06801405已完成不适用

Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction. A Retrospective Cohort Study

Barretos Cancer Hospital1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2021年4月2日最近更新:
适应症
干预措施
相关药物

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

发起方
Barretos Cancer Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeferson Rodrigo Zanon

Principal Investigator

Barretos Cancer Hospital

研究点 (1)

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