Assessment of Oncological and Functional Outcomes After Robot Assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy
NCT02924922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2020-09-01
Summary
Currently, partial nephrectomy (PN) is considered as the gold standard treatment modality for small renal masses. In this setting, robot-assisted and conventional laparoscopic approaches are gaining more consensus every day. However, until now, no superiority of one technique over the other has yet been demonstrated, especially on postoperative function recovery.
This study compares oncological and functional outcomes after laparoscopic partial nephrectomy versus robot assisted partial nephrectomy.
Conditions
- Kidney Neoplasms
Interventions
- PROCEDURE
-
Laparoscopic partial nephrectomy
The renal hilus is identified and both vein and artery are dissected. A laparoscopic ultrasound probe is introduced through a 12 mm port to define the tumor resection margins. A laparoscopic Satinsky clamp is used to induce total kidney ischemia, clamping both vein and artery. Athermal resection of the tumor is performed and titanium clips are used to close interlobar or arcuate arteries encountered during resection. The defect is closed with stitches secured by Hem-o-Lok clips and haemostatic glue. Ischemia is interrupted once renorrhaphy is completed
- PROCEDURE
-
Robot assisted partial nephrectomy
The renal hilus is carefully dissected, so that the arterial segmental branches are reached. Tumor resection margins are identified through ultrasound. Drop-in bulldog clamps are used to clamp segmental arterial branches and induce selective ischemia. Indocyanine green 0.2-0.3mg/KG is infused intravenously a few seconds after the selective ischemia is induced. The Firefly near infra-red fluorescence system is used to determine the extent of the ischemic area. The ischemic zone can now be tailored to the tumor by adding or removing bulldog clamps according to the vascular anatomical conditions. Athermal resection of the tumor is performed and titanium clips are used to close interlobar or arcuate arteries encountered during resection. The resection defect is closed with stitches secured by Hem-o-Lok clips and haemostatic glue. Selective ischemia will be interrupted once renorrhaphy is completed
- DEVICE
-
Conventional laparoscopic instruments
Endoscope, Scissor, Needleholder, Forceps, Suction unit, Ports, Tissel, CO2, Sutures, Needles, Scalpel, Ultrasound-Probe, Monitors
- DEVICE
-
Da- Vinci Robot and conventional laparoscopic instruments
Da Vinci Robot, Console, Ports and Instruments; Suction unit, Forceps, Tisseel, Ultrasound Probe, Monitors
- DRUG
-
Mannitol
Sponsors & Collaborators
-
Swiss Paraplegic Research, Nottwil
collaborator NETWORK -
Luzerner Kantonsspital
lead OTHER
Principal Investigators
-
Agostino Mattei, Ass. Prof. · Luzerner Kantonsspital Luzern, Leiter der Klinik für Urologie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2018-12-31
- Completion
- 2019-04-01
Countries
- Switzerland
Study Locations
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