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临床试验/NCT07197385
NCT07197385已完成不适用

Comparison of Ureteroscopic Lithotripsy and Laparoscopic Ureterolithotomy for the Treatment of Unilateral Upper Ureteral Stone

Lahore General Hospital2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Stone-Free Rate (SFR)

研究概览

简要总结

Kidney stones are a common health problem that can cause severe pain, blockage of urine flow, and even long-term kidney damage if left untreated. When stones move from the kidney into the upper part of the ureter (the tube that carries urine to the bladder), treatment often becomes more difficult. Several treatment options are available, including breaking the stones with sound waves, removing them with small telescopes, or performing surgery. However, the best method for larger stones in the upper ureter is still debated.

This study will compare two commonly used minimally invasive surgical techniques for removing upper ureteral stones. The first method is ureteroscopic lithotripsy (URS), in which a thin scope is passed through the urinary passage to directly reach the stone and break it into small pieces using a pneumatic device. The second method is laparoscopic ureterolithotomy (LU), a keyhole surgical procedure in which small incisions are made in the abdomen, and the stone is removed directly through the ureter.

Fifty-six adult patients with a single upper ureteral stone measuring 10-20 mm will be randomly assigned to either URS or LU. Both groups will undergo standard preoperative evaluations, and infection will be treated before surgery. The outcomes will be assessed in terms of operation time, length of hospital stay, level of postoperative pain, use of pain medications, complications during or after surgery, and the stone-free rate (absence of residual stone fragments larger than 3 mm after four weeks).

By comparing these two procedures, this study aims to identify which treatment is safer and more effective for patients with upper ureteral stones. The results will provide useful evidence to guide doctors and patients in making the best treatment choices.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both genders with age ≥ 18 years.
  • Patients with a duration of symptoms for more than 1 month.
  • Patients having a unilateral single stone of 10 mm to 20 mm in diameter, located between the ureteropelvic junction and the upper border of the sacroiliac joint (upper ureteral stone).

排除标准

  • Patients with a history of ipsilateral ureteric surgeries, previous open abdominal surgeries, bleeding disorders and pregnancy.
  • Before surgery, patients had a positive urine culture, fever (37.60c) and leukocytosis > 12.000 per microliter.
  • Patients having solitary kidney and co-morbidities e.g., cardiovascular, Liver, respiratory illnesses, or serum creatinine >1.5 mg/dl.
  • Horseshoe kidneys, pelvic kidneys, pyonephrosis, ureteropelvic junction blockage, and ureteral stricture.
  • Patients with unsuitable for general anesthesia.

结局指标

主要结局

Stone-Free Rate (SFR)

时间窗: At 4 weeks postoperatively (before removal of DJ stent).

The stone-free rate will be defined as the absence of residual stone fragments \>3 mm, confirmed by radiological imaging (X-ray KUB or NCCT) at follow-up. Patients with residual fragments ≤3 mm will be considered stone-free, while those with larger fragments or requiring auxiliary procedures will be considered not stone-free.

Operative Time

时间窗: Intraoperative, recorded at the time of surgery

Operative time will be measured from the start of the surgical procedure until urethral catheterization is completed. The duration will be recorded in minutes for each patient and compared between ureteroscopic lithotripsy and laparoscopic ureterolithotomy groups.

次要结局

  • Postoperative Pain (VAS Score)(Day of surgery and postoperative day 1.)

研究者

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

Muhammad Irfan Jamil

Principal Investigator

Lahore General Hospital

研究点 (2)

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