The Combined Effect of Antibiotic Irrigation and Aspiration Ureteral Access Sheath on Infectious Complications in Retrograde Intrarenal Surgery: A Prospective Randomized Factorial Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
研究概览
简要总结
Retrograde intrarenal surgery (RIRS) is a widely used treatment for kidney stones; however, postoperative infectious complications remain a significant concern. This prospective randomized factorial trial aims to evaluate whether gentamicin-containing irrigation fluid and the use of a suction ureteral access sheath can reduce postoperative fever, systemic inflammatory response syndrome (SIRS), and sepsis after RIRS. The study will also investigate the independent and combined effects of these two interventions on infectious outcomes.
详细描述
Subject:
The present study aims to investigate the effects of gentamicin-containing irrigation and the use of a suction ureteral access sheath during retrograde intrarenal surgery (RIRS) on postoperative infectious complications.
Objective:
The aim of this study is to evaluate the independent and combined effects of gentamicin irrigation and a suction ureteral access sheath on postoperative infectious complications following RIRS.
Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive treatment modality for renal stones, particularly for stones up to 20 mm. Although RIRS is generally considered safe and effective, postoperative infectious complications remain an important clinical concern. Fever, urinary tract infection, systemic inflammatory response syndrome (SIRS), and sepsis may occur even in patients with negative preoperative urine cultures and appropriate perioperative antibiotic prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for retrograde intrarenal surgery (RIRS) due to kidney stones
- •Male and female patients aged 18 years or older
- •Patients who voluntarily sign the informed consent form
- •Patients with sterile urine culture or whose preoperative infection has been treated and urine culture has become sterile
排除标准
- •Patients with active urinary tract infection before surgery
- •Patients with chronic kidney disease
- •Pregnant patients
- •Patients with allergy to aminoglycoside-group drugs used in the study protocol, specifically gentamicin
- •Cases in which the ureter cannot be accessed and the procedure is postponed by placing a double-J stent instead of performing dilation
研究组 & 干预措施
Standard RIRS
Participants in this arm will undergo standard retrograde intrarenal surgery using standard saline irrigation and a standard ureteral access sheath. This arm will serve as the control group for comparison with gentamicin irrigation, suction-enabled ureteral access sheath use, and the combined intervention.
干预措施: Standard Retrograde Intrarenal Surgery (Procedure)
Standard RIRS With Gentamicin Irrigation
Arm Description:
Participants in this arm will undergo standard retrograde intrarenal surgery using gentamicin-containing irrigation fluid. Gentamicin will be added to normal saline irrigation solution during the procedure. A standard ureteral access sheath will be used without suction assistance.
干预措施: Standard Retrograde Intrarenal Surgery (Procedure)
Standard RIRS With Gentamicin Irrigation
Arm Description:
Participants in this arm will undergo standard retrograde intrarenal surgery using gentamicin-containing irrigation fluid. Gentamicin will be added to normal saline irrigation solution during the procedure. A standard ureteral access sheath will be used without suction assistance.
干预措施: Gentamicin Irrigation (Drug)
Suction RIRS
Participants in this arm will undergo retrograde intrarenal surgery using a suction-enabled ureteral access sheath. The suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure. Standard saline irrigation will be used without gentamicin.
干预措施: Suction-Enabled Ureteral Access Sheath (Device)
Suction RIRS With Gentamicin Irrigation
Participants in this arm will undergo retrograde intrarenal surgery using both gentamicin-containing irrigation fluid and a suction-enabled ureteral access sheath. Gentamicin will be added to normal saline irrigation solution, and the suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure.
干预措施: Gentamicin Irrigation (Drug)
Suction RIRS With Gentamicin Irrigation
Participants in this arm will undergo retrograde intrarenal surgery using both gentamicin-containing irrigation fluid and a suction-enabled ureteral access sheath. Gentamicin will be added to normal saline irrigation solution, and the suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure.
干预措施: Suction-Enabled Ureteral Access Sheath (Device)
研究者
Mustafa Serdar CAGLAYAN
Assistant Professor
Hitit University