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
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
- 是
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
Mahmoud Ahmed Gaber
Principle investigator
Assiut University
