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临床试验/NCT06734455
NCT06734455已完成不适用

Robot-Assisted Laparoscopic Pyeloplasty in Children Younger Than 5 Years Old

Destinval Christelle1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9
试验地点
1
主要终点
Presence of ureterohydronephrosis

研究概览

简要总结

The goal of this retrospective study is to analyse the outcomes of Robot-Assisted Pyeloplasty in participants younger than 5 years old:

  • indication criteria
  • clinical symptoms
  • operating time
  • length of stay
  • complications
  • follow-up

详细描述

Outcomes of Robot-Assisted Pyeloplasty in participants younger than 5 years old and comparison with the outcomes in the literature.

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

入选标准

  • Patients younger than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022

排除标准

  • Patients older than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022

结局指标

主要结局

Presence of ureterohydronephrosis

时间窗: Before surgery

Ureterohydronephrosis represents the augmentation of the diameter of the ureter (more than 10 millimeters) and the renal pelvis (more than 30 millimeters), which can be measured on imaging such as abdominal ultrasound, CT scan, or MRI. Whenever the ureter and the renal pelvis meet these criteria on preoperative imaging, the patient will be labeled as having ureterohydronephrosis.

Presence of abdominal pain

时间窗: Before surgery

Flank pain (pain in the upper abdomen or back)

Presence of urinary calculi

时间窗: Before surgery

Urinary calculi can be diagnosed on an abdominal X-Ray, an abdominal Ultrasound or an abdominal CT scan

Presence of abnormal nuclear renal scans

时间窗: Before surgery

Nuclear renal scans are abnormal when there is a difference of filtration of more than 40% between the kidneys

Presence of urinary tract infection

时间窗: Before surgery

Urinary tract infection associated with ureteropelvic junction

次要结局

  • Postoperative pain(After surgery and before discharge home, up to 20 days)
  • Postoperative complications(Through study completion, an average of 2 years)
  • Operation time(During surgery)
  • Hospitalization length(From admission to discharge home, up to 20 days)

研究者

发起方
Destinval Christelle
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Destinval Christelle

M.D.

University Hospital, Clermont-Ferrand

研究点 (1)

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