跳至主要内容
临床试验/NCT07238803
NCT07238803招募中不适用

Outcomes of Using Flexible and Navigable Suction Sheath With Flexible Ureteroscopy in Treatment of Lower Calyceal Stones: A Prospective Study

Zagazig University2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
33
试验地点
2
主要终点
Evaluation of Stone-Free Rate Following Flexible Ureteroscopy with FANS sheath for Management of Renal and Ureteral Calculi.

研究概览

简要总结

The aim of this study is to evaluate and assess the outcomes of flexible ureteroscopy (FURS) with flexible and navigable suction UAS (FANS) in the treatment of lower calyceal stones.

详细描述

With the continued advancements of technology and increasing experience gained by urologists in ureteroscopic skills, fURS has become a standard treatment for kidney stones lesser than 2 cm in diameter. In the previous the European guidelines and American Urologic Association guidelines for management of urolithiasis, fURS were recommended as a second-line treatment for stones less than 2 cm after ESWL, however in the recent revision of the guidelines, RIRS can be used as the first-line management option especially for stones measuring between 11 and 20 mm.

The ureteral access sheath (UAS), initially introduced by Hisao Takayasu in 1974 Despite continued advances in retrograde intrarenal surgery (RIRS), recent real-world data for 6669 patients in the FLEXOR registry revealed residual fragments in 21.7% of patients, of whom 51.5% required a second intervention.

The sepsis rate in the same study was just 1.3%. Hence, there is still much to improve in terms of technical expertise and technology for RIRS. Many aids have been introduced to streamline RIRS and improve procedural success. These include suction via a scope or ureteral access sheath (UAS), postintervention catheters, slimmer single-use scopes, and high-power lasers, these improvements have made RIRS a standard of care according to international guidelines.

It has been reported that vacuum aided or suction aspiration sheaths have strong potential to improve the stone-free status (SFS) rate and minimize infectious compilations associated with the negative effects of high intrarenal pressure and temperature, However, the true potential of the advances for RIRS has yet to be investigated. The ideal game-changing technological innovation for RIRS should improve all key outcomes of the procedure, including the rate of immediate single stage SFS, perioperative and postoperative complications, and the reintervention rate for residual fragments. One recent advance that has shown much promise is a flexible and navigable sheath (FANS) So, we will conduct a prospective study to assess whether FANS could be a potential game-changer for RIRS in adults with lower calyceal stones instead of traditional UAS especially regarding stone-free rates (SFR), complications and cost.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Adult patients ≥ 18 years old.
  • Patients with lower calyceal stones scheduled for FURS.

排除标准

  • patients with active urinary tract infections.
  • Patients with renal and ureteric anomalies.
  • patients with coagulopathy
  • patients who are refusing to participate.

结局指标

主要结局

Evaluation of Stone-Free Rate Following Flexible Ureteroscopy with FANS sheath for Management of Renal and Ureteral Calculi.

时间窗: 1 month after the procedure (preferred and most common for SFR assessment)

This clinical study aims to evaluate the stone-free rate (SFR) following flexible ureteroscopy (FURS) in patients with renal or ureteral calculi. The primary outcome measure is the proportion of patients who achieve complete stone clearance, as determined by postoperative imaging (non-contrast CT or ultrasound) within a defined follow-up period.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mahmoud Ahmed Elsayed Ahmed Lasheen

Urology Resident

Zagazig University

研究点 (2)

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