Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
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
- 否
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)
