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临床试验/NCT03503539
NCT03503539已完成不适用

Are the Stone Density and Location Useful Parameters That Can Determine the Endourological Surgical Technique for Kidney Stones That Are Smaller Than 2 cm? Prospective Randomized Controlled Trial

Abant Izzet Baysal University0 个研究点目标入组 60 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Stone free rate

研究概览

简要总结

The investigators aimed to evaluate whether these parameters could be guides for us in the selection of RIRS or Mini-PNL procedures in kidney stones that are smaller than 2 cm.

The patients that have kidney stones smaller than two cm and be planned to undergo surgery were randomized into 2 groups prospectively. RIRS was performed in the RIRS group using a 7.5-F fiberoptic flexible ureterorenoscope while Mini-PCNL group was dilated up to 16.5F and mini-PCNL was performed with 12F nephroscopy. Preoperative characteristics, operative and postoperative results were compared in two groups. Thereafter, intra and intergroup comparisons were made to determine the effects of HU value, indicating the stone density, higher or less than 677 and the stone location on stone-free rates.

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

性别
All
接受健康志愿者

入选标准

  • Patients were evaluated with non-contrast abdominopelvic CT after a detailed anamnesis and physical examination.
  • Patients, who had a kidney stone with a maximum diameter of less than 2 cm and who did not prefer to undergo ESWL, were taken into the study.

排除标准

  • Patients with anomalous kidneys, skeletal deformities, severe obesity (BMI> 35) and those underwent ESWL treatment previously for the same stone were excluded from the study.

研究组 & 干预措施

Mini percutaneous nephrolithotomy

Experimental

All operations were performed or supervised by the same surgeon. Right after the patients in mini-PNL group were placed a 5F ureteral catheter with general anesthesia, they were had a prone position and the access was performed by choosing the optimal calyx to reach the stone following the contrast agent was given. The guide wire was then placed and the stones were broken with a laser lithotripter using a 12F nephroscope (Modular minimally invasive PCNL system, Karl Storz, Tuttlingen, Germany) following the dilatation using an one step dilator with a 16.5F access sheath. When necessary, stones were removed using the stone removal forceps. Right after a 14-Fr nephrostomy tube was inserted and an antegrade pyelography was taken, the operation was terminated.

干预措施: Mini percutaneous nephrolithotomy (Procedure)

Retrograde intrarenal surgery

Active Comparator

Following the general anesthesia performed, a safety guide wire was placed and semirigid ureteroscopy (9.5 / 11.5F) was performed. Stones were fragmented using a 270 micron meter laser fiber with the help of 7.5-F fiber optic flexible ureterorenoscope after the placement of ureteral access sheat (9.5 / 11.5 F). Stone fragmentation was accomplished using a laser energy of 0.5-1.5 J and a rate of 5-15 Hz and adjusting this range according to stone hardness. 4.7F JJ stent was routinely placed at the end of the operation because of worries about possible edema etc. due to access sheath. In this group, access sheath could not be placed in 2 patients due to the small diameter of the ureter, and JJ stent was placed, and 2 weeks later, the procedure was performed as it was in the others.

干预措施: Retrograde intrarenal surgery (Procedure)

结局指标

主要结局

Stone free rate

时间窗: 1 year

Stone-free conditions were determined by low-dose spiral CT taken in postoperative third month

次要结局

  • Mean fluoroscopy time(İntraoperative duration of flouroscopy)

研究者

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

Adnan Gucuk

Associate Professor

Abant Izzet Baysal University

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