Effect of Preoperative Tamsulosin and Silodosin on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-Prestented Patients During Retrograde Intrarenal Surgery (RIRS). Assessment of Factors for Successful Ureteral Access Sheath Insertion. Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- successful of ureteral access sheath insertion
研究概览
简要总结
The aim of the study is to evaluate the effect of preoperative taking alpha-blockers (tamsulosin or silodosin) on the success rate of ureteral access sheath (UAS) insertion and the degree of ureteral injury during RIRS in non-prestented patients.
The results showed that patients who received alpha-blockers had a higher rate of successful UAS insertion and a lower degree of ureteral injury compared to non-prestented patients. In addition, patients with a BMI greater than 25 kg/m² and those older than 59 years demonstrated a higher success rate of UAS insertion and lower degree of ureteral injury.
详细描述
Study Title:
Effect of Preoperative Tamsulosin and Silodosin on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-Prestented Patients During Retrograde Intrarenal Surgery (RIRS). Assessment of factors for successful ureteral access sheath insertion. Randomized clinical trial.
Study Design:
Prospective, randomized, open-label, controlled trial with four parallel arms. Conducted from July 2021 to June 2024.
Study Center:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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 aged 18 years and older
- •Kidney stone size: ≤2 cm
- •Stone density >1000 Hounsfield units
- •Sterile urine culture
排除标准
- •Congenital anomalies of the urinary tract
- •Urinary tract infections
- •Upper urinary tract obstruction
- •Prior reconstructive surgeries on the upper urinary tract
结局指标
主要结局
successful of ureteral access sheath insertion
时间窗: Intraoperative
Proportion of patients with successful UAS insertion
Inflammatory markers
时间窗: Baseline and 24 hours postoperatively
Change in in blood Leukocyte count, 10⁹/L C- reactive protein , mg/l
degree of ureteral injury
时间窗: Perioperative
Assessed using the PULS scale.Post-Ureteral Lesion Scale. Grade 0: No injury - intact ureter with no visible damage. Grade 1: Superficial mucosal injury - minor abrasions or erosions without disruption of the ureteral wall. Grade 2: Partial thickness injury - damage involving part of the ureteral wall, without full-thickness perforation; may have localized bleeding. Grade 3: Full-thickness ureteral injury - perforation of the ureteral wall with urine leakage, but the injury is limited in size. Grade 4: Extensive ureteral damage - large perforation with significant tissue destruction. Grade 5: Complete transection or avulsion - full disruption with loss of ureteral tissue, typically requiring complex reconstructive surgery.
postoperative pain
时间窗: 6, 24, and 48 hours postoperatively
Patient-reported pain intensity. The Visual Analog Scale for Pain (VASP) is a widely used, validated tool for the subjective measurement of pain intensity. It consists of a straight line, typically 10 centimeters (100 millimeters) in length, anchored by two verbal descriptors: "no pain" at the zero end and "worst imaginable pain" at the opposite end. Participants rate their current pain level by marking a point along the line that corresponds to their perception of pain intensity. The distance from the zero point to the mark (measured in millimeters or centimeters) quantifies the pain intensity on a continuous scale from 0 to 10 (or 0 to 100).
Factors influencing successful ureteral access sheath insertion
时间窗: Until the completion of the study, on average 1 year
Multivariate analysis of factors influencing successful UAS insetion. BMI of the patient - kg/m² Age of the patient
次要结局
- Operative time(Intraoperative (measured from start to end of procedure))
- Postoperative complications(through study completion, an average of 1 year)
研究者
Mikheev Yury
urologist, St. Luke's Clinical Hospital
St. Luke's Clinical Hospital, Russia