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临床试验/NCT06350045
NCT06350045进行中(未招募)4 期

Renal Puncture Above the Eleventh Rib (High Supracostal Approach) Versus Subcostal Puncture in Percutaneous Nephrolithotomy for Treatment of Renal Stones in Adults: A Prospective Randomized Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
162
试验地点
2
主要终点
Stone free rate

研究概览

简要总结

as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one

详细描述

The use of percutaneous nephrolithotomy (PCNL) was first reported by Fernström and Johansson in 1976. Percutaneous nephrolithotomy (PCNL) is the accepted treatment for staghorn stones, large renal stones, and some upper ureteric stones. Achieving suitable access to the appropriate calyx is one of the most important steps during the PCNL procedure. Effective puncture is key for the success of PCNL. An ideal percutaneous nephrolithotomy (PCNL) puncture has been described as one that provides the shortest and straightest access to all calculi, avoids major vessels, bowel and lung, lies along the axis of the calyx and causes minimal parenchymal damage.

Many studies have reported that supracostal access for PCNL is advantageous over infracostal access. By creating a straight path along the kidney's long axis, the upper-pole method guarantees access to the majority of the collecting system and makes it simpler to manipulate the rigid nephroscope and other rigid devices. Therefore, supracostal puncture is perhaps the greatest method for gaining access to the upper pole calyx, where staghorn and big, complicated renal stones are most likely to be located. Although pneumothorax, hydrothorax, and lung damage (1-10%) can result after a supracostal puncture, this injury can now be handled with minimal morbidity thanks to advances in surgical technique and understanding of pleural and diaphragmatic architecture.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

closed envelop

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old.
  • Patients amenable for PCNL with stone burden between 2 cm - 4 cm (guy score 1-2-3)

排除标准

  • Ectopic kidney.
  • Single middle calyceal stone.
  • Skeletal anomalies.
  • Bleeding diathesis.
  • Active urinary tract infection.
  • Patient refusing participation.
  • Patients with active pulmonary and pleural disease.

结局指标

主要结局

Stone free rate

时间窗: within 3 months post operative

the patient being either completely stone-free or there are residual fragments (less than 4 mm).

Rate of complications

时间窗: within 3 months post operative

Clavien -Dindo classification.

次要结局

  • duration of Hospital stay.(Postoperativly)
  • Operative time(intraoperative)

研究者

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

Mahmoud Ahmed Gaber

Principle investigator

Assiut University

研究点 (2)

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