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临床试验/NCT06249100
NCT06249100已完成2 期

Flexible Mini Percutaneous Nephrolithotomy Vs Retrograde Intra-renal Surgery for Treatment of Renal Stones: a Randomized Controlled Trial

Ain Shams University2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
130
试验地点
2
主要终点
stone-free rate

研究概览

简要总结

The use of flexible ureteroscopy and minimally-invasive percutaneous techniques, which utilize smaller tract sizes, has been established as a way to decrease the invasiveness of procedures and improve patient outcomes compared to conventional percutaneous nephrolithotomy (PCNL) and flexible mini-PCNL has emerged as a novel technique previously first as an auxiliary procedure and then as a standalone technique. This study aims to assess the feasibility and effectiveness of flexible nephoscopy in improving stone clearance compared to standard retrograde intrarenal surgery using a flexible ureteroscope.

详细描述

Urinary stones are one of the most common rising health concerns around the world. Urolithiasis is particularly common in high-income countries, with more than 10% of people suffering from it. Renal stones often manifest as colicky loin pain, often known as renal colic.

Percutaneous nephrolithotomy (PCNL) is highly recommended by international guidelines as the primary treatment for renal stones larger than 20 mm. However, for stones ranging from 10 to 20 mm in size, treatment options may include shock wave lithotripsy (SWL), PCNL, or retrograde intrarenal surgery (RIRS).

Significant advancements have been achieved in surgical techniques recently, leading to the emergence of minimally invasive percutaneous nephrolithotomy (mini-PCNL) as a viable and effective treatment option for the removal of large renal and proximal ureteral stones.

In recent years, there has been a consistent reduction in the size of endoscopic instruments. The primary objective of these tools is to minimize the amount of blood lost during surgery, lower the occurrence of complications both during and after the operation, and ultimately reduce the length of hospital stays.

Despite the use of a smaller nephroscope, the rigidity of the mini-nephroscope poses a limitation in maneuvering into renal calyces at acute angles. This limitation may necessitate the creation of additional tracts, leading to an increase in morbidity. To tackle this challenge, a new technique flexible mini-nephroscope has been developed. This innovative instrument allows for access to all regions of the pelvi-caliceal system through a single access tract.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients above the age of 16 years of either sex presented to the Urology clinic in our university hospitals
  • kidney stones with a size not exceeding 3.0 cm (estimated by CTUT as the greatest dimension or the summation of the greatest dimensions in case of more than one stone detected)

排除标准

  • Patients with lumber hernia on the same site of the surgery
  • Patients with a stone burden exceeding 3cm
  • Patients with renal anomalies preventing access
  • Patients with coagulopathies/bleeding tendency
  • Patients with untreated or active UTI

结局指标

主要结局

stone-free rate

时间窗: 1 month postoperative

patients will be considered stone free, if the stone residual in the follow up is less than 4mm

次要结局

  • Hemoglobin drop(1 day postoperative)
  • Hospital Stay(1 month postoperative)
  • Cost analysis(1 month postoperative)
  • Operative time(24 hour postoperative)
  • infection rate(up to 1 month postoperative)

研究者

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

Ahmed Maher Gamil Ahmed Higazy

principle investigator

Ain Shams University

研究点 (2)

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