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临床试验/NCT06510790
NCT06510790已完成不适用

Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent: a Prospective Study

Tribhuvan University Teaching Hospital, Institute Of Medicine.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Risk factors associated with bacterial colonization of DJS.

研究概览

简要总结

The goal of this prospective study is to identify the risk factors associated with bacterial colonization of DJS and report the common microorganisms isolated and drug susceptibility pattern.

详细描述

This was a hospital-based prospective observational study performed at a tertiary academic center from March 2022 to August 2023.

All patients coming to TUTH OPD and ER for urological surgery were assessed for the placement of a DJS (polyurethane). Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures. All patients received prophylactic antibiotic therapy with levofloxacin for 2 to 3 days at the time of DJS insertion. The DJS was in situ until the duration allocated according to the procedure. The DJS was removed in 2 weeks postoperatively with aseptic precaution under local anesthesia (2% lignocaine jelly) with the help of a 30-degree Karl Storze scope with cystoscope sheath 19/21 and alligator forceps following the standard technique. The equipment was sterilized with a 2.45% Cidex solution for 12 minutes prior to all DJS removal. Then the patient was positioned in the lithotomy position, with proper cleaning of the external genitalia with povidone-iodine 10%, complete separation of the labia in the female, and proper cleaning of the prepuce and glans in the male. Then sterile xylocaine jelly 2% was instilled in the urethra, a cystoscope was inserted into the bladder, alligator forceps were inserted, and a DJS was removed. After removal of the DJS with sterile technique, the tips of both ends (renal end and bladder end) of the stent were cut with surgical blade number 10 and collected in a plastic screw-capped container, and sent for bacterial evaluation.

The report of the culture and sensitivity pattern were collected and treated according to the sensitivity pattern with appropriate antibiotics correlating with the symptoms. Colonization is defined as the growth of microorganisms in the tip culture of either end or both ends of DJS. All the demographic data with other study variables were recorded in proforma. Any amount of preoperative urine albumin from trace amounts and above (+,++, etc.) was considered in this study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing DJ stent placement

排除标准

  • Positive urine culture before stenting
  • Taking antibiotics during DJS removal
  • Presence of yeasts in urine culture
  • Declining informed consent

结局指标

主要结局

Risk factors associated with bacterial colonization of DJS.

时间窗: 4 weeks

Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures.

次要结局

  • The common microorganisms isolated from DJS in culture along with their drug susceptibility pattern.(4 weeks)

研究者

发起方
Tribhuvan University Teaching Hospital, Institute Of Medicine.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ishwor Thapaliya

Prinicpal Investigator

Tribhuvan University Teaching Hospital, Institute Of Medicine.

研究点 (1)

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