Prospective Multicenter Observational Study of Early Infancy Ureteral Reimplantation for Distal Ureteral Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Reoperation
研究概览
简要总结
Prospective multicenter observational study of early infancy ureteral reimplantation for distal ureteral obstruction.
The study is an observation study since the investigators will not assign specific interventions to the subjects of the study.
The purpose of the study is to describe the surgical outcomes of early infancy ureteral reimplantation. Infants under 6 months of age with unilateral obstructed distal ureter, no other urologic pathologic and a normal contralateral kidney who have been recommended a ureteral reimplant by their pediatric urologist are eligible for the study. Patients that consent for the study will be prospectively followed for 1 year to record the outcomes of the surgery.
详细描述
Initial evaluation and determining if surgery is indicated:
Prenatal diagnosis: patient will get renal ultrasound at 2-7 days of birth and will be started on prophylaxis with amoxicillin or Keflex. At 6 weeks a VCUG, renal ultrasound and mag 3 will be done per local protocols.
Patients considered for reimplant will have:
- SFU grade 3 and 4 hydroureteronephrosis
- Normal contralateral kidney (VUR grade 1-3 ok) as defined above plus
- Obstruction As defined by the BAPU (British Association of Paediatric Urologists consensus statement on the management of the primary obstructive megaureter)
If the patient meets criteria they will be consented for this observational study (before the surgery) and will have an extravesical ureteral reimplant in the next 0-2 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Reoperation
时间窗: 1 year
Need for reoperation either for persistent documented obstruction or reflux with recurrent febrile UTI's
次要结局
- Recurrent Febrile UTI's(1 year)