The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications: A Prospective Randomized Double Blinded Placebo Controlled Pilot Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- infectious complications
研究概览
简要总结
The aim of this clinical study is to evaluate the safety and efficacy of addition of gentamicin on irrigation fluid during trans-urethral resection of the prostate (TURP) and its role in reduction of post-TURP infectious complications.
the participants will be randomly divided into two groups: Group A (gentamicin group) and group B (Placebo).
详细描述
220 patients scheduled for TURP for the management of urinary retention or LUTS will be included and divided into two groups; "Group A" includes 110 patients who will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation) and "Group B" includes 110 patients who will undergo TURP with addition of normal saline (2 ml) as a placebo on the irrigation solution. Determination of Gentamicin in human serum using HPLC/UV after Chemical Derivatization will be done using the method of Barends et al (Barends, Brouwers, & Hulshoff, 1987). Both groups will be compared as regards the demographic data, post-operative pyuria and bacteruria (1 week after removal of urethral catheter), fever, and/or sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •adult patients with enlarged prostate presenting with LUTS or urine retention
排除标准
- •Unfit patients
- •Renal impairment
- •active UTI
- •urethral strictures
研究组 & 干预措施
Garamicin group
the participants in this arm will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)
干预措施: Transurethral resection of the prostate (TURP) (Procedure)
Garamicin group
the participants in this arm will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)
干预措施: Gentamicin (Drug)
control group
the participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo).
干预措施: Transurethral resection of the prostate (TURP) (Procedure)
control group
the participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo).
干预措施: normal saline (Drug)
结局指标
主要结局
infectious complications
时间窗: 1 week and 1 month after removal of urethral catheter
Post-TURP pyuria and bacteruria
次要结局
未报告次要终点
研究者
Ahmed Zoeir
faculty of medicine, Tanta, ElGeish street, Egypt
Tanta University