A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) Versus Traditional Access Sheath in RIRS : Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- • Stone-free rate (SFR).
研究概览
简要总结
A comparative study between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus Traditional Access sheath in RIRS : Randomized controlled trial .
详细描述
Urinary calculus is a worldwide urological disease, with a prevalence ranging from 1% to 13% in different regions . Currently, the main therapeutic methods beyond conservative treatment for renal calculi include extracorporeal shock wave lithotripsy (ESWL) and minimally invasive endoscopic surgical methods, including percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). Treatment plans depend on the characteristics of calculi, patient factors, surgeon experience and the condition of medical centers .
Technological advancements in RIRS have been numerous in recent years, with the introduction of single-use flexible ureteroscopes and higher-power lasers being the most notable. High intrarenal pressure (IRP) can lead to pyelovenous backflow and infection from transient bacteraemia, particularly during laser lithotripsy. Another major concern is the retention of residual fragments (RFs), which are pieces that are hidden from view because of the snow-globe effect .
Therefore, in order to facilitate the clearance of RF and enhance the overall performance of RIRS, a variety of adjuncts have been developed, including pressure sensors to regulate IRP, a direct in-scope vacuum technique to aspirate dust, and stone retrieval devices that utilize suction technologies .
These objectives are all designed to achieve the triumvirate of successful RIRS: a high stone-free rate (SFR), minimal ancillary interventions, and minimal complications-the ultimate goal of all RIRS surgeons .
The ureteral access sheath (UAS) has been used in RIRS to reduce IRP and hence infectious complications, as well as to improve drainage, stone clearance, and intraoperative vision, thus shortening operative time. However, there still remains some debate over the ideal UAS size - too large risks injuring the ureteral mucosa and causing ischaemia, while too small defeats its purpose of improving drainage .
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥14 years old in patients not known to have stone forming medical conditions.
- •Renal stones diameter of ≤2 cm confirmed by CT with all types of configurations (branching & non-branching).
- •Non - recurrent cases with no history of previous open renal surgeries or PCNL with normal renal anatomy.
- •Patients with non - infected urine analysis.
排除标准
- •Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit).
- •Patients with medical conditions promoting stone formation (hyperparathyroidism - gout).
- •Patients with history of stones on the same side with previous open surgical intervention or PCNL .
- •Patients with e-GFR < 60 ml / min.
- •Patients with uncontrolled urinary tract infection.
- •Patients with health or other factors that are absolute contraindications to RIRS.
- •Patients who are unable to understand or complete trial documentation.
研究组 & 干预措施
Using FANS
After the successful induction of anesthesia, the lithotomy position will be adopted. Ureteroscopy will be used with the aid of a safety guidewire to evaluate the condition of the ureter. The serial dilation of the ureter using ureteral dilators up to 14 Fr . The FANS will be then inserted into the ureter under the guidance of the safety guidewire. The FANS tip will be positioned in the renal pelvis or calyces near the location of the stone.
The FANS will be connected to a vacuum device, and the negative pressure will be applied. The actual intraoperative negative pressure value will be adjusted by the urologist through a pressure adjustment vent as needed. The irrigation volume was set using peristaltic pumps. Lithotripsy will be conducted using the holmium: yttrium aluminum garnet laser applying the dusting technique of laser lithotripsy. During lithotripsy, the FANS will allow us to retrieve most of the fragmented stone particles by application of the suction pressure. All cases w
干预措施: FURS (Procedure)
Using traditional UAS
The method of anesthesia, patient positioning, ureteral dilation, and lithotripsy were the same as those used in the FANS group.
For the traditional UAS group, the end of the UAS will be positioned underneath the ureteropelvic junction (UPJ). The irrigation volume is applied using peristaltic pumps. The dusting technique of laser lithotripsy will be applied to the stones.
All cases will be stented using JJ stents with the suitable size.
干预措施: FURS (Procedure)
结局指标
主要结局
• Stone-free rate (SFR).
时间窗: 12 weeks postoperatively
次要结局
未报告次要终点
研究者
Yosseif elhousseiny ammar ahmed
Principal investigator
Cairo University