Evaluation Trifecta and Pentafecta Outcomes of Patients Underwent Laparoscopic Partial Nephrectomy for cT1 Renal Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- Operation time
研究概览
简要总结
The aim of the study is to evaluate trifecta and pentafecta outcomes for laparoscopic partial nephrectomy (LNP) in patients with clinical T1N0M0 renal tumor.
详细描述
From November 2009 to August 2018 a total of 292 patients who underwent LPN by global ischemia were included in the study. The patients were allocated into two groups according to the tumor size; T1a (≤ 40 mm, n=215), T1b (41-70 mm, n=77). Demographics features, clinical tumor characteristics, intraoperative and postoperative outcomes were analyzed. A negative surgical margin, warm ischemia time (WIT) < 20 min and no postoperative complications (Clavien-Dindo ≥ grade 3) were accepted to achieve the trifecta outcomes. Pentafecta has defined as trifecta criteria plus >90% preservation of estimated glomerular filtration rate (eGFR) and no stage upgrade of chronic kidney disease 12 months after LPN. Univariable and multivariable analysis were used to identify factors predicting trifecta and pentafecta achievement.
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 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functioning contraleteral kidney
- •Patients with complete data
- •Patients with single renal tumor on the effected side
- •Patients who approved the written consent form
排除标准
- •The patients with bilateral renal tumors (n=8, 16 LPNs)
- •solitary kidney (n=8)
- •horseshoe kidney (n=4)
- •pelvic ectopic kidney (n=2)
- •graft kidney (n=2)
- •those with multiple renal tumors in a single kidney (n=3) or with > 7 cm renal tumor (n=6)
- •Patients who were operated on for colon cancer (n=4), prostate cancer (n=2), endometrial cancer (n=1) or adrenal mass (n=2) within the first year after LPN
结局指标
主要结局
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)
CKD stage upgrading
时间窗: up to 1 year postoperatively
evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages
Oncological outomes
时间窗: up to the last clinical control (months)
Presence or absence of local and/or distal tumor recurrence
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
intraoperative complication
时间窗: at the end of the surgery
abnormal problmes that may be seen during surgery
Postoperative complication
时间窗: up to 3 months
abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up
functional outcomes
时间窗: up to 1 year postoperatively
serum creatinine level and estimated glomerular filtration rate
surigcal margin status
时间窗: up to 1 month postoperatively
presence or absence of tumors at the surgical margin
Relative decrease in renal function
时间窗: up to 1 year postoperatively
Comparison of preoperative and postoperative renal functions according to numerical and percentile values
次要结局
未报告次要终点
研究者
Mehmet Necmettin Mercimek
Principal Investigator
Samsun Liv Hospital