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临床试验/NCT06350942
NCT06350942已完成不适用

One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication

National Children's Hospital, Vietnam2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Median length of hospital stays

研究概览

简要总结

Ureteral duplication, a common anomaly affecting about 0.8% of the population, presents challenges in pediatric urology due to its diverse clinical presentations and anatomical complexity. Traditional treatments like upper pole moiety (UPM) heminephrectomy can lead to loss of renal function in the remaining lower pole moiety (LPM). Ureteroureterostomy (UU) is a safer alternative, increasingly preferred regardless of renal function or reflux presence. Minimally invasive techniques like laparoscopic and robotic procedures show promise, but robotic-assisted UU is costly, while laparoscopic UU has technical challenges. A novel approach is proposed: single-trocar retroperitoneoscopic-assisted UU, combining laparoscopic visualization advantages with simplified extracorporeal suturing, offering a promising solution for managing complete ureteral duplication. The present study was designed to describe the operative technique and outcome of OTAU in 40 cases of complete ureteral duplication in children.

详细描述

Ureteral duplication, a common anomaly affecting about 0.8% of the population, presents challenges in pediatric urology due to its diverse clinical presentations and anatomical complexity. Traditional treatments like upper pole moiety (UPM) heminephrectomy can lead to loss of renal function in the remaining lower pole moiety (LPM). Ureteroureterostomy (UU) is a safer alternative, increasingly preferred regardless of renal function or reflux presence. Minimally invasive techniques like laparoscopic and robotic procedures show promise, but robotic-assisted UU is costly, while laparoscopic UU has technical challenges. A novel approach is proposed: single-trocar retroperitoneoscopic-assisted UU, combining laparoscopic visualization advantages with simplified extracorporeal suturing, offering a promising solution for managing complete ureteral duplication. The present study was designed to describe the operative technique and outcome of OTAU in 40 cases of complete ureteral duplication in children.

Demographic data of patients, their clinical manifestations, classification of hydronephrosis based on the guidelines established by the Society for Fetal Urology (SFU), dimensions of the renal pelvis measured in the anterior-posterior direction (APD), diameters of the ureters, duration of surgical procedures, duration of hospitalization, and subsequent follow-up information were systematically gathered prospectively to evaluate the long-term outcomes of the proposing surgical technique.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Month 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of ureteral duplication.
  • Age no more than 18 years old
  • The surgical technique performed must be one trocar-assisted retroperitoneoscopic ureteroureterostomy.
  • Followed up at least 2-4 years

排除标准

  • Patients exhibiting reflux to the ureter of the lower pole moiety (LPM)
  • Patients with prior urologic surgeries or other urological anomalies

结局指标

主要结局

Median length of hospital stays

时间窗: through study completion (4 years)

Average time (days) the patient has to stay at the hospital post-operation

Intraoperative complications

时间窗: through study completion (4 years)

Complications experienced during the procedure

Mean operating time

时间窗: through study completion (4 years)

The average operating time (minutes) of OTAU

Conversion to open

时间窗: through study completion (4 years)

Incidence in which the operation must be switch to open surgery

Mean SFU of UPM renal pelvis

时间窗: through study completion (4 years)

The average Society of Fetal Urology classification of the upper pole moiety before and after the operation

Mean UPM renal pelvis' APD

时间窗: through study completion (4 years)

The average anterior-posterior diameter (mm) of the upper pole moiety before and after the operation

Early postoperative complications

时间窗: through study completion (4 years)

Complications after OTAU including UTI and wound infection

Mean UPM DRF

时间窗: through study completion (4 years)

The average differential renal function (%) (measurement of each kidney's ability to extract tracer from blood) of the upper pole moiety before and after operation

Mean UPM ureter's diameter

时间窗: through study completion (4 years)

The average ureter's diameter (mm) of the upper pole moiety before and after the operation

Mean DRF of operated side

时间窗: through study completion (4 years)

The average differential renal function (%) of the operated side before and after operation

次要结局

未报告次要终点

研究者

发起方
National Children's Hospital, Vietnam
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nguyen Thanh Quang

Pediatric Surgeon

National Children's Hospital, Vietnam

研究点 (2)

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