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临床试验/NCT06349161
NCT06349161已完成不适用

Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience

National Children's Hospital, Vietnam1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年5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
70
试验地点
1
主要终点
Conversion to open

研究概览

简要总结

Open surgical dismembered pyeloplasty has traditionally been the preferred method for treating ureteropelvic junction obstruction (UPJO), with a success rate exceeding 94%. However, it is associated with drawbacks such as increased postoperative pain, extended hospital stays, and visible scarring. Minimally invasive alternatives, including laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP), have gained popularity since their introduction in 1993, offering comparable success rates to open surgery while providing cosmetic benefits and shorter hospital stays. Nevertheless, these techniques present challenges in pediatric patients, including limited working space, technical complexities, and prolonged operative times. The retroperitoneoscopic one-trocar-assisted pyeloplasty (OTAP) method, introduced in 2007, combines the advantages of minimally invasive surgery with the success rates of standard dismembered pyeloplasty. Despite favorable outcomes reported by several researchers, comprehensive studies regarding long-term follow-up and clinical outcomes are lacking. This study aims to evaluate the long-term outcomes of OTAP, addressing this gap in the medical literature.

详细描述

Open surgical dismembered pyeloplasty has historically been the gold standard for managing ureteropelvic junction obstruction (UPJO), boasting a success rate exceeding 94%. However, the requisite incision and muscle dissection can lead to increased postoperative pain, prolonged hospitalization, and undesirable scarring. In recent decades, there has been a growing interest in minimally invasive pyeloplasty, commencing with its inception in 1993. Laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP) have emerged as widely embraced and dependable therapeutic modalities for UPJO. Both techniques have demonstrated success rates comparable to those of open pyeloplasty while conferring advantages in terms of cosmetic outcomes and length of hospital stay.

However, despite their merits, minimally invasive approaches pose certain limitations in pediatric patients, including restricted working space, technical intricacies, prolonged operative time, steep learning curves, and the need for expensive instrumentation. Conventional laparoscopic pyeloplasty has encountered slow uptake due to its technical demands and substantial learning curve. The evolution of RALP over the past decade appears to mitigate the learning curve associated with intracorporeal suturing and anastomosis time. Nonetheless, RALP necessitates three to four port placements and a sizeable initial financial investment.

In 2007, Lima et al. introduced the retroperitoneoscopic one-trocar-assisted pyeloplasty (OTAP) approach, which "combines the advantages of a minimally invasive technique with the high success rate of standard dismembered pyeloplasty". Several other researchers have replicated this technique with favorable outcomes. Nevertheless, a dearth of comprehensive studies delineating long-term follow-up and clinical outcomes persists in the medical literature. The aim of this study is to evaluate the long-term outcomes of OTAP.

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
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 6 months to 5 years old with UPJ obstruction who underwent OTAP between May 2011 and June
  • Anteroposterior renal pelvic diameter of 20 mm or greater, which demonstrated progressive enlargement on subsequent ultrasounds, coupled with impaired split renal function of 40% or less on nuclear scan, characterized by a T1/2 > 20 minutes
  • The surgical technique performed must be one trocar-assisted pyeloplasty

排除标准

  • A history of previous renal surgery
  • UPJO associated with other urinary tract anomalies
  • Identification of crossing lower pole renal vessels as the cause of obstruction.

结局指标

主要结局

Conversion to open

时间窗: through study completion (3 years)

Incidence in which the operation must be switch to open surgery

Post-operative mean DRF

时间窗: through study completion (3 years)

The average different renal function (%) (measurement of each kidney's ability to extract tracer from blood) after the operation

Postoperative complications

时间窗: through study completion (3 years)

Complications after OTAP including febrile UTI

Operative time

时间窗: through study completion (3 years)

The average and range of operative time (minutes) using the OTAP technique

Extension of skin incision

时间窗: through study completion (3 years)

Incidence in which the original incision of the skin must be extended to accommodate UPJ mobilization

Median follow up length

时间窗: through study completion (3 years)

The average time (months) the patient revisit the hospital for follow-up sessions

Median length of hospital stays

时间窗: through study completion (3 years)

The average time (days) the patient stays at the hospital post-operation

Post-operative mean APD

时间窗: through study completion (3 years)

The average anterior posterior diameter (mm) of the renal pelvis post-operation

Recurrence

时间窗: through study completion (3 years)

Instances of symptoms reappeared after the completion of the surgery

Mean incision length

时间窗: through study completion (3 years)

The average length (mm) of the primary incision during the 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 (1)

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