Predictors of Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors
研究概览
简要总结
Background: Partial nephrectomy (PN) is a reference standard for the management of the cT1 renal mass, primarily due to better preservation of renal function. The aim of this work was to determine trifecta outcomes of open PN (OPN) and laparoscopic PN (LPN) and identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and ischemia time less than 25 minutes.
Objectives: this study pointing to determine trifecta outcomes of OPN and LPN and to identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and Ischemia time less than 25 Minutes.
详细描述
Methods: This prospective, randomized study was carried out on 35 patients with clinical T1 N0M0 renal tumors. Patients were divided into two groups: Group A (n=38): underwent OPN and group B (n=32): underwent LPN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients who are fit for surgery.
- •Patients with renal tumor who are indicated for partial nephrectomy
- •Solitary kidney.
- •Bilateral renal tumor.
- •Abnormal contralateral kidney (nephropathy, nephrolithiasis, trauma).
- •Metabolic disease associated with renal failure (DM, hypertension).
- •Genetic syndrome with tumor multifocality (VHL syndrome). Elective
- •Clinical T1N0M0 Tumor.
- •Peripheral tumor.
排除标准
- •• Patients who are unfit for surgery and who's unfit for laparoscopy.
- •Patients who are contraindicated for partial nephrectomy. As severe and irreversible coagulopathy. Patients who are indicated for radical nephrectomy (extensive tumor, metastatic tumor).
研究组 & 干预措施
open partial nephrectomy
open partial nephrectomy
干预措施: open partial nephrectomy (Procedure)
laparoscopic partial nephrectomy
laparoscopic partial nephrectomy
干预措施: laparoscopic partial nephrectomy (Procedure)
结局指标
主要结局
Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors
时间窗: 2 years
Trifecta achievement is defined as the combination of (1) negative surgical margins, (2) absence of perioperative complications classified as Clavien-Dindo grade III or higher, and (3) warm ischemia time ≤25 minutes. factors affecting trifecta achievement among variables including tumor complexity score, patient comorbidities, BMI, surgical approches, special habbites, age or gender.
次要结局
- Pentafecta Achivement(2 yrs)
研究者
Omar Ahmad Bakheet
Assistant Lecturer
South Valley University