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临床试验/NCT06424080
NCT06424080招募中不适用

Oncological and Perioperative Outcomes of Laparoscopic Versus Robotic Partial Nephrectomy for Treatment of Renal Tumors.

Menoufia University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
to compare between laparoscopic and robotic partial nephrectomy regards ischemia time

研究概览

简要总结

partial nephrectomy offers lower renal function impairment and equivalent oncological survival outcomes compared with radical nephrectomy in those with T1 tumors.

As urology has embraced the gradual shift from open to minimally invasive surgery (MIS), PN is being completed more often by laparoscopic and robotic methods .

The first laparoscopic transperitoneal partial nephrectomy was reported in 1993 by Winfield, with the retroperitoneal approach introduced 1 year later With advancing robotic technology and the development of the DaVinci system, urologists began to explore the realm of robotic-assisted urologic surgery. In 2004, Gettman et al. published a paper describing their experience with robotic-assisted laparoscopic partial nephrectomy.

Moreover, robotic assisted partial nephrectomy (RAPN) and laparoscopic partial nephrectomy (LPN) seems to be significantly better than OPN in terms of perioperative complications, estimated blood loss and hospital stay. Conversely, transfusion rate, ischemia time, change in estimated glomerular filtration rate and early cancer outcomes are similar between the two approaches. International guidelines recommend the use of both approaches according to the surgeon and patient preferences.

so, we are plaining to do the study comparing between RAPN and LPN regarding feasibility and ability of both techniques.

详细描述

Renal cell carcinoma (RCC) represents a significant burden of malignancy. Over the past 2-3 decades, the incidence of kidney cancer has steadily increased all around the world ,.The EUA Guidelines suggested that surgery is the only curative treatment for localized renal cell carcinoma.

Surgical treatment of RCC either radical or partial nephrectomy is related to the clinical stage of the disease and to the general condition of the patient. Modern medical imaging has further revolutionized the role of PN due to the increasing volume of incidentally diagnosed small renal masses.

Indeed, partial nephrectomy offers lower renal function impairment and equivalent oncological survival outcomes compared with radical nephrectomy in those with T1 tumors.

As urology has embraced the gradual shift from open to minimally invasive surgery (MIS), PN is being completed more often by laparoscopic and robotic methods .

The first laparoscopic transperitoneal partial nephrectomy was reported in 1993 by Winfield, with the retroperitoneal approach introduced 1 year later With advancing robotic technology and the development of the DaVinci system, urologists began to explore the realm of robotic-assisted urologic surgery. In 2004, Gettman et al. published a paper describing their experience with robotic-assisted laparoscopic partial nephrectomy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • renal mass T1 according to TNM amenable for partial nephrectomy.

排除标准

  • any unfit pt for partial nephrectomy
  • more than 7cm tumor
  • mass not amenable for partial nephrectomy
  • metastatic tumor or locally advanced

结局指标

主要结局

to compare between laparoscopic and robotic partial nephrectomy regards ischemia time

时间窗: 1 year

to compare between laparoscopic and robotic partial nephrectomy regards ischemia time

次要结局

  • compare between laparoscopic and robotic partial nephrectomy pathological safty margin(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Kandeel

Yassin Abdelghaffar st-from Gamal Abdel Nasar st- faculty of medicine

Menoufia University

研究点 (2)

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