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临床试验/NCT06684756
NCT06684756招募中不适用

The Comparison of the Efficacy and Safety of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Randomized Controlled Prospective Multicenter Study

Namik Kemal University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
Stone free rates

研究概览

简要总结

This study aims to compare the efficacy and safety, the ratio of stone-free rates, and complications of two types of access sheaths used in retrograde intrarenal surgery to treat upper urothelial stones. The access sheath types are those with vacuum aspiration and the conventional ones.

详细描述

The use of ureteral access sheath (UAS) during Retrograde Intrarenal Surgery (RIRS) has been proven effective and reliable in recent years, and publications indicate that it reduces stone-free rates (SFR). Their use is also recommended in the European Urology Guidelines because it improves image quality, reduces intrarenal pressure, and shortens the operation time. For this reason, it has been routinely used in many RIRS cases. In cases where non-vacuum-assisted UAS is used, fragments during stone fragmentation remain in the kidney, and since it is not possible to remove the stones simultaneously, the image may be distorted, and the operation duration may be prolonged. All these may pave the way for postoperative infectious complications. In addition to non-vacuum-assisted UAS, new UASs with flexible ends and vacuum-assisted aspiration have been introduced in the last few years (ClearPetra). Thanks to the aspiration connected to the system, stone fragments can be removed from the body with negative pressure during stone fragmentation. Continuous circulation prevents bleeding during fragmentation and blurring of the visual field due to stone fragments. In addition, since the stone fragments pass through the edges of the sheath without breaking and are removed, a perfect field of view can be provided. Unlike the classical UAS, the tip is flexible, allowing for the safe removal of lower pole stones. Many studies in the literature compare the success and complications of RIRS in cases where conventional UAS was used and not used. In addition, there are publications related to using the newly introduced aspiration access sheath in percutaneous nephrolithotomy. In retrospective publications on using this UAS in RIRS, it has been shown that stone-free rates, operation time, hemoglobin loss, and postoperative infective complications are more successful on the 1st and 30th postoperative days compared to cases where non-vacuum-assisted UAS was used. There is no randomized controlled prospective publication on this subject. This study aims to compare the complications and stone-free rates of RIRS cases where non-vacuum-assisted UAS and new vacuum-assisted UAS were used.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years of age
  • Patients below 85 years of age
  • Patients with 11-13 FR conventional/vacuum-assisted ureteral access sheath (UAS) during retrograde intrarenal surgery

排除标准

  • Patients with non-sterile preoperative urine culture
  • Patients with renal anatomic anomalies
  • Patients with a solitary (single) kidney
  • Patients with insufficient data
  • Patients under the age of 18, above the age of 85
  • Patients without an UAS during RIRS
  • Patients without 11-13Fr UAS during RIRS

研究组 & 干预措施

Patients with conventional UAS being used in their RIRS operations

Active Comparator

The patient population will be selected from cases determined by randomization and used with UAS without an aspiration (conventional) during RIRS.

干预措施: Retrograde intrarenal surgery (Procedure)

Patients with vacuum assisted UAS being used in their RIRS operations

Experimental

The patient population will be selected from cases determined by randomization and used with UAS with an aspiration and flexible tip, different from the conventional one during RIRS.

干预措施: Retrograde intrarenal surgery (Procedure)

结局指标

主要结局

Stone free rates

时间窗: Stone-free status will be checked by performing a non-contrast abdominal CT scan 1 month after the operation.

Presence/absence of residual fragments in postoperative imaging, if any, diameter of longest axis in mm.

次要结局

  • Complication rates(Peroperative complication rates will be determined during the operation, and postoperative complications will be re-evaluated during hospitalization before discharge or in the first month after discharge.)

研究者

发起方
Namik Kemal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Fatih Şahin

Assistant Professor

Namik Kemal University

研究点 (2)

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