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临床试验/NCT06142734
NCT06142734尚未招募不适用

Laparoscopic Versus Mini-incision Open Dismembered Pyeloplasty for Treatment of Ureteropelvic Junction Obstruction in Children: a Comparative Randomized Trial.

Ahmed Mahmoud Abdelraouf0 个研究点目标入组 40 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Operative time

研究概览

简要总结

Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay

详细描述

Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Indications for surgical intervention include impaired split renal function (< 40%), a decrease of split renal function of > 10% in subsequent studies, poor drainage function after the administration of furosemide, increased anteroposterior diameter on US, and grade III and IV dilatation as defined by the Society for Fetal Urology. The open dismembered pyeloplasty was the historical gold standard repair of uretropelvic junction obstruction. Schuessler et al. introduced the first laparoscopic pyeloplasty (LP) 1993 followed by Peters et al, who performed the first pediatric laparoscopic pyeloplasty. Since then, minimally invasive pyeloplasty (MIP) -laparoscopic and robotic assisted- had an increasing interest among urologists and became widely adopted by many centers as a standard surgical intervention in UPJ obstruction; thanks to the decreased postoperative pain, short hospital stay, reduced postoperative recovery time, and comparable success rates. The high cost and long learning curve hindered generalization of MIP in all centers. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay . Tanaka et al. have reported that the benefits of laparoscopic pyeloplasty were evident only in older children . Till now 85% of infants are still treated with open pyeloplasty . According to the EAU guidelines 2023 "There does not seem to be any clear benefit of minimally invasive procedures in a very young child but current data are insufficient to defer a cut-off age " .

Most of the studies that compared open to LP didn't limit cases to mini-incision open pyeloplasty.

To our knowledge there is no prospective randomized study comparing laparoscopic to open pyeloplasty with mini-incision in children to date.

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
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children between 1-18 years , males and females with UPJ obstruction in orthotopic kidney indicated for dismembered pyeloplasty and not else

排除标准

  • Recurrent UPJ obstruction.
  • Cases that require technique other than dismembered pyeloplasty
  • Patients that have contradiction to laparoscopy.
  • comorbidities that prevent surgery e.g: uncorrected coagulopathy and vertebro-spinal deformity
  • patient refusing participation in the study.

结局指标

主要结局

Operative time

时间窗: baseline

From incision to last stitch

次要结局

未报告次要终点

研究者

发起方
Ahmed Mahmoud Abdelraouf
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Mahmoud Abdelraouf

Assistant lecturer of Urology

Assiut University

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