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临床试验/NCT02160652
NCT02160652Unknown不适用

Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction

Rabin Medical Center0 个研究点目标入组 50 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Ureteral patency - 6 months

研究概览

简要总结

A single center single arm prospective study, assessing the outcome of ureteral re-implantation for malignant ureteral obstruction.

详细描述

The Research Question: Is laparoscopic ureteral re-implantation, for the treatment of malignant ureteral obstruction, associated with high patency rates, low complication rates, and a significant improvement in quality of life?

Study design: A single center single arm prospective study, assessing the outcome of ureteral re-implantation for malignant ureteral obstruction.

Study population: Patients with malignant ureteral obstruction, treated with laparoscopic ureteral re-implantation, who have a life expectancy of over 6 months and are willing and able to participate in the study.

Intervention: Laparoscopic ureteral re-implantation.

Study Time line: This will be a 1 year study. At initiation a baseline physical exam, blood test, and ultrasonography will be performed. Baseline quality of life questionnaires will be filled. After the operation, Follow-up visits will occur at 1, 3, 6 and 12 months after surgery. At each follow up visit a medical history and physical examination, blood tests and quality of life questionnaires will be performed. At 3, 6 and 12 months renal ultrasonography will be performed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Ureteral patency - 6 months

时间窗: 6 months following the operation

Ureteral patency at 6 months following the operation- assessed by stable or improved hydronephrosis and estimated GFR according to the CKD-EPI equation.

次要结局

  • Ureteral patency - 12 months(12 months following the operation)
  • Post-operative complications(1, 3, 6, and 12-months following the operation)
  • Quality of life(1,3,6, and 12 months following the operation)
  • Re-intervention(12 months following the operation)

研究者

申办方类型
Other
责任方
Sponsor

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