Transperitoneal Laparoscopic Pyelolithotomy: Is the Posterior Pyelotomy Better Than the Anterior? (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Days for oral intake
研究概览
简要总结
Large renal pelvic stones are frequently managed with percutaneous nephrolithotomy (PCNL) but laparoscopic pyelolithotomy (LPL) can be an alternative procedure when performed by skilled surgeons to achieve excellent outcomes in terms of stone free status, operative time, postoperative kidney function, hospitalization duration, and complications.
there are two methods for LPL surgery : Transperitoneal (TLP) and Retroperitoneal (RLP).
RLP associated with shorter mean time for oral intake, and mean hospital stay after surgery.
The surgical exposure in the transperitoneal route for LP is familiar to the majority of surgeons. Also, a much larger working space is available and there are various established anatomical landmarks for performing the surgery effectively. This study introduces a modified technique that creates application of posterior pyelotomy in TLP to achieve the advantages of RLP
详细描述
This is a randomized controlled clinical trial that aims to collect a sample within two years from the date of approval of the Scientific Research Council at Damascus University.
The study will focus on a group of patients who will undergo a transperitoneal laparoscopic pyelolithotomy surgery.
The patients will be randomly divided into two groups. The first group will undergo a traditional transperitoneal laparoscopic pyelolithotomy, which involves application of anterior pyelotomy.
The second group will receive a modified transperitoneal laparoscopic pyelolithotomy, which involves application of posterior pyelotomy.
The data will be compared between the two groups in terms of the mean duration of surgery ,mean time for oral intake ,and mean hospital stay
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with large renal pelvic stone > 2 cm .
- •failure of minimally invasive approaches such as PCNL or ESWL
- •stones that were neither amenable to ESWL nor were ideally suitable for PCNL
- •Patient's preference for a quick one-stage procedure.
- •Negative urine culture
排除标准
- •Patients refusing study participation.
- •Contraindication to general anesthesia.
- •Contraindication to laparoscopic surgery.
- •Patients with an intrarenal pelvis.
- •Previous surgical on the same kidney.
- •Associated anatomical deformity.
结局指标
主要结局
Days for oral intake
时间窗: Up to one week after surgery
the number of days to start introducing oral fluids and food after surgery with good acceptance, and without vomiting or flatulence. It will be measured in the outcome by the mean
Postoperative urine leak
时间窗: up to three days after surgery
considered to be present when the drain contained \>30 cc of urine the morning after surgery. It is measured by answering the question: Is there any urinary leakage, yes or no? It will be measured in the outcome by the ratio
Days of hospital stay
时间窗: up to ten days after surgery
the number of days the patient stayed in the hospital after surgery. It will be measured in the outcome by the mean
Operative time
时间窗: at the end of surgery in the operating room
the duration of the surgical procedure. It is measured by minutes, and calculated from establishing the pneumoperitoneum until the surgery is completed by suturing the skin. It will be measured in the outcome by the mean
stone-free status
时间窗: Up to one week after surgery
postoperative radiological imaging demonstrating evidence of residual stones It will be measured in the Outcome by the ratio
次要结局
未报告次要终点