An International Multicenter Study on the Antimicrobial Prophylaxis Strategy for Flexible Ureteroscopic Lithotripsy Combined With a Flexible Negative Pressure Suction Sheath
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively
研究概览
简要总结
This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.
详细描述
This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.
This trial is an international, multicenter, prospective, randomized controlled trial. The participating centers are: Shanghai General Hospital (lead institution), Shanghai Xinhua Hospital, Weifang Traditional Chinese Medicine Hospital, School of Medicine, Mulawarman University Abdul Wahab Sjahranie Hospital (Indonesia), and Hospital Raja Perempuan Zainab II (Malaysia).
This trial will employ a non-inferiority design and a central randomization system to allocate eligible subjects in a 1:1 ratio to either the experimental group (no prophylactic antimicrobials) or the control group (single-dose antimicrobial prophylaxis). Stratification factors will include the participating center and stone size, with subjects stratified by the longest stone diameter: ≤1.5cm and >1.5cm but ≤2cm.
All surgeries will be performed by surgeons with experience of ≥50 cases of flexible negative-pressure sheath procedures, using a standardized surgical record form to document key operational parameters (e.g., sheath model, negative pressure settings, operative time, irrigation volume, etc.). Prior to study initiation, all centers will undergo standardized surgical video training and simulated operational assessments to ensure technical consistency.
The surgery will follow standardized technical parameters: a F10/12, F11/13, or F12/14 flexible negative-pressure sheath will be selected based on the patient's ureteral conditions; the central negative pressure will be set to 0.02-0.04MPa; the irrigation flow rate will be 50-150 ml/min, adjusted to the minimum rate that both maintains collecting system filling and ensures low intrarenal pressure; and the lithotripsy will employ a 'simultaneous fragmentation and suction for in-situ stone clearance' strategy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years.
- •Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm.
- •Scheduled to undergo fURS lithotripsy.
- •No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative.
- •No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities.
- •No use of long-acting antimicrobial agents within 7 days prior to surgery, and no use of intermediate or short-acting antimicrobial agents within 72 hours prior to surgery.
- •Has signed and dated an informed consent form, indicating that the patient or their legal representative has been fully informed about the study-related information and has agreed to participate.
排除标准
- •Pregnant or lactating women.
- •Allergy to the investigational drug(s).
- •Participation in other clinical trials within 30 days.
- •Presence of other active infection foci requiring antimicrobial treatment.
- •Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states.
- •Congenital malformations of the urinary tract.
- •History of kidney transplantation or urinary diversion surgery.
- •Unable to provide samples or complete follow-up according to the study protocol.
- •Unable to provide informed consent.
- •Inability to achieve complete placement of the flexible negative-pressure suction sheath.
- •Any other conditions that the investigator deems unsuitable for participation in this study.
- •History of diabetes mellitus, immunocompromised.
- •Renal insufficiency, neurogenic bladder.
- •Recent preoperative history of stone-related fever.
- •Long-term indwelling urinary drainage tube.
- •Urine white blood cells >5/HPF (High Power Field) or positive for urine nitrites.
- •Large stone burden (e.g., staghorn calculus) or moderate to severe hydronephrosis.
- •Imaging findings showing turbid urine in the renal pelvis where pyonephrosis or infectious stones cannot be excluded.
研究组 & 干预措施
Group 1
Undergo flexible ureteroscopic lithotripsy and stone clearance with a flexible negative-pressure sheath without the use of any prophylactic antimicrobials; postoperatively, therapeutic antimicrobials will be initiated only for patients who develop signs or symptoms of infection.
干预措施: not use any prophylactic antimicrobials (Drug)
Group 2
Receive a single dose of intravenous prophylactic antimicrobials (e.g., a second-generation cephalosporin or levofloxacin) 30-60 minutes before surgery, followed by the same standardized flexible negative-pressure sheath ureteroscopic surgery.
干预措施: use prophylactic antimicrobials (Drug)
结局指标
主要结局
the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively
时间窗: within 72 hours postoperatively
To reduce the influence of subjective factors and to more comprehensively reflect the systemic inflammatory state, the primary endpoint is the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively, defined as meeting at least two of the following criteria: Body temperature \>38°C or \<36°C Heart rate \>90 beats/minute Respiratory rate \>20 breaths/minute or PaCO2 \<32 mmHg White blood cell count \>12×10⁹/L or \<4×10⁹/L, or \>10% immature neutrophils
次要结局
未报告次要终点
研究者
Yi Shao
Director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine