Comparison of Laparoscopic Partial Nephrectomy Versus Laparoscopic Radical Nephrectomy in Patients With High-Complexity Renal Tumors: A Propensity Score Matched Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Postoperative complication
研究概览
简要总结
The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.
详细描述
From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD), and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with complete data
- •Patients with single renal tumor on the effected side
- •Patients who approved the written consent form
排除标准
- •Patients who not approved the written consent form
- •Patients with incomplete data
- •Patients with low or mild complexity renal tumors
结局指标
主要结局
Postoperative complication
时间窗: up to 3 months postoperatively
abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up
functional outcomes
时间窗: 1 year after the surgery
serum creatinine level (mg /dL) and estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)
surigcal margin status
时间窗: postoperative follow-up, through study completion, an average of 1 year
presence or absence of tumors at the surgical margin
CKD stage upgrading
时间窗: postoperative follow-up, through study completion, an average of 1 year
evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages
Oncological outomes
时间窗: postoperative follow-up, through study completion, an average of 1 year
Presence or absence of local and/or distal tumor recurrence
Operation time
时间窗: at the end of the surgery
time from onset to complete of surgery
Blood loss
时间窗: at the end of the surgery
amount of bleeding during surgery (mL)
warm ischemia time
时间窗: at the and of the surgery
The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy
次要结局
未报告次要终点
研究者
Mehmet Necmettin Mercimek
Principal Investigator
Samsun Liv Hospital