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临床试验/NCT05377632
NCT05377632已完成不适用

Comparing the Modified Novel Trans-Retro Approach vs Conventional Retroperitoneal Approach in Robotic-Assisted Renal Surgery: An Open Label Randomized Controlled Trial

Lukas J Hefermehl1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
detection of the renal artery

研究概览

简要总结

The purpose of this study is to determine if the novel TR approach is superior to the standard RP approach. The anticipated study outcome is a time saving of at least 30% from first skin incision to detection of the renal artery compared to the conventional RP approach, and also a better workspace perception by the operating surgeon.

详细描述

The trans abdominal approach (TA) for total and partial nephrectomy (PN) has been widely adopted due to the easy trocar placement and the good working space. The retroperitoneal approach (RP) has gained popularity because the renal artery is often found fast and the operation remains in an anatomically separated space, making it preferable, especially for patients who underwent abdominal surgery in the past. However, both approaches face difficulties. Trocar placement for RP can be challenging, and the working space often is limited, while TA is impaired in cases of dorsal tumors and dissection of the renal artery can be challenging due to the anatomic localization dorsally to the renal vein. Up until now, no direct systematically and prospective comparison of these two approaches was performed.

The overall objective of this trial is to assess if the novel TR approach is superior to the conventional RP approach in performing robotic assisted (partial) nephrectomy. To date, no systematic, prospective, randomised study has been conducted on this topic and described in the literature.

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

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

入选标准

  • •Age 18 years or older
  • •Patient with a renal tumor or non-functionally kidney that is a candidate for robotic assisted surgery (RAS) nephrectomy or partial nephrectomy (PN)
  • •Informed Consent as documented by signature (Appendix Informed Consent Form)

排除标准

  • •Renal vein tumor thrombus
  • •Pregnancy or suspected pregnancy

研究组 & 干预措施

Hybrid-Group

Active Comparator

Laparoscopic and Robotic-assisted combined (partial) nephrectomy via the hybrid (trans-peritoneal and retroperitoneal) access route

干预措施: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) (Procedure)

Retroperitoneal-Group

Active Comparator

Robotic-assisted laparoscopic (partial) nephrectomy via the retroperitoneal access route

干预措施: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) (Procedure)

结局指标

主要结局

detection of the renal artery

时间窗: During procedure/surgery

Time from first skin incision to detection of the renal artery \[Time in minutes\]

次要结局

  • Surgical conversion to radical nephrectomy(During procedure/surgery)
  • Comprehensive Complication Index(Day 30)
  • Console surgeons perception of Trocar placement and working space(During procedure/surgery)
  • Side assistants perception of Trocar placement and working space(During procedure/surgery)
  • Procedure related reoperations(Day 30)
  • Operative time(During procedure/surgery)
  • Intraoperative blood loss(During procedure/surgery)
  • Robot docking time(During procedure/surgery)
  • Instrument insertion time(During procedure/surgery)
  • Ischemia time(During procedure/surgery)
  • Surgical conversion to open surgery(During procedure/surgery)
  • Off-console time(During procedure/surgery)
  • Pain assessment(During the hospital stay (up to day 7))
  • Procedure related readmissions(Day 30)
  • Pain Management(During the hospital stay (up to day 7))
  • Kidney function via the estimated glomerular filtration rate (eGRF)(During the hospital stay (up to day 7))
  • Post operative complications(Day 30)
  • Length of stay Length of stay(During the hospital stay (up to day 7))

研究者

发起方
Lukas J Hefermehl
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lukas J Hefermehl

Principal Investigator

Kantonsspital Baden

研究点 (1)

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