German National Registry for Nephron-Sparing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 137
- 试验地点
- 5
- 主要终点
- Survival
研究概览
简要总结
The G-NeSS Registry prospectively collects data on clinical and outcome variables from patients undergoing partial nephrectomy for renal masses. Analyses of data aims at identifying key factors determining the quality of surgical care in this patient population.
详细描述
Today the majority of patients with renal tumors is diagnosed with localized disease amenable to nephron-sparing surgery (NSS). Partial nephrectomy (PN) constitutes the reference standard treatment for small renal masses according to international guidelines. Open PN ist still the predominant apporach in Germany, but the use of minimally-invasive surgery has continously increased over the last decades. Specifically, robotic surgery is on the rise and may facilitate the adoption of a minimally-invasive PN approach even in more complex renal tumours. Real world data on the outcomes of PN according to the surgical approach are limited. Data from cancer registries and health insurance databases usually lack important information an key patient und tumour characteristics, such as tumour complexity.
The G-NESS registry database aims at prospectively collecting such clinical and outcome data from patients undergoing PN. Data collection includes perioperative variables on patient characteristics, tumour location and complexity, surgical approach, intra-/postoperative complications, and kidney function. Follow-up based on questionnaires is conducted after predefined intervals (i.e. 30 days, 12 months, 24 months, and 60 months) in order to receive information on long-term kidney function, comorbidities, and survival. The information received from the database can help to better define the optimal surgical care for patients with renal masses.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Written informed consent
- •Localized renal parenchymal mass amenable to nephron-sparing surgery
- •Adequate imaging of the abdomen (CT or MR with contrast)
排除标准
- •Patient with (or suspected to have) urothelial cancer of the kidney
- •Prior nephron-sparing surgery on ipsilateral kidney
- •metastasized renal cell carcinoma
结局指标
主要结局
Survival
时间窗: 60 months
Overall Survival
Complication rate
时间窗: 60 months
Complication rate according to Clavien-Dindo in %
Postoperative glomerular inflitration rate
时间窗: 60 months
Rate in ml/min.
次要结局
未报告次要终点
