A Prospective Randomized Study Comparing Open Versus Laparoscopic Dismembered Pyeloplasty Among Adult Patients With Primary Pelvi-Ureteric Junction Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Amount of blood loss
研究概览
简要总结
To prospectively compare the perioperative, morphological and functional outcomes on short and medium term between laparoscopic (LP) and open pyeloplasty (OP) patients.
详细描述
Pelvi-ureteric junction obstruction (PUJO) is defined as a functionally significant impairment of the flow of urine from the kidney's renal pelvis into the proximal ureter.
Open pyeloplasty (OP) has been the gold standard for PUJO repair since the first successful reconstruction of an obstructed PUJO was accomplished in 1892, and achieves success rates exceeding 90%.
Various open surgical techniques have been described based on the cause, location, and length of the PUJO. The most popular repair is the Anderson-Hynes dismembered pyeloplasty, which has universal application and is accepted as the gold standard of treatment.
Now, Laparoscopic dismembered pyeloplasty represents a minimally invasive alternative of gold standard open Anderson- Hynes technique that has a comparable successful outcome with open pyeloplasty while avoiding its co-morbidities. It is also better than endopylotomy as it deals effectively with the crossing vessel
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
- 否
入选标准
- •All adult patients (above 18 years old) with primary pelvi-ureteric junction obstruction indicated for active intervention as
- •Symptoms such as recurrent flank pain, recurrent urinary tract infection and rarely hypertension.
- •Breakthrough urinary tract infections while on prophylactic antibiotics.
- •Increasing renal antero-posterior diameter, or decreasing renal parenchymal thickness by ultrasound.
- •Low or decreasing differential renal function, but above 10%.
排除标准
- •Patients having poor ipsilateral renal function < 10%.
- •Patients with previous pelvi-ureteric junction obstruction repair.
- •Associated renal stones.
- •Patients unfit for surgery according to American Society of Anesthesiologists classification.
- •Contraindications for laparoscopy as (marked obesity, large ventral hernias, gross coagulopathy, abdominal wall sepsis, vertebral deformities…).
- •Pediatric patients.
- •Pregnant women.
- •Vesicoureteral reflux.
- •Congenital renal anomalies as (horse- shoe kidney, pelvic kidney, mal- rotated kidney ...).
- •Single functioning kidney.
- •Malignancy.
- •Refusal of written consent.
研究组 & 干预措施
Laparoscopic pyeloplasty
Patients underwent laparoscopic pyeloplasty.
干预措施: Laparoscopic pyeloplasty (Procedure)
Open pyeloplasty
Patients underwent open pyeloplasty.
干预措施: Open pyeloplasty (Procedure)
结局指标
主要结局
Amount of blood loss
时间窗: Intraoperatively
Amount of blood loss was recorded.
次要结局
- Complications(24 hours postoperatively)
- Etiology of obstruction(Intraoperatively)
研究者
Mina Soliman Messiha Georgy
Resident of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University