Assessment of Oncological and Functional Outcomes After Robot Assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy

NACompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

April 1, 2019

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

Trial Locations (1)

6000

Klinik für Urologie, Kantonsspital Luzern, Lucerne

All Listed Sponsors
collaborator

Swiss Paraplegic Research, Nottwil

NETWORK

lead

Luzerner Kantonsspital

OTHER

NCT02924922 - Assessment of Oncological and Functional Outcomes After Robot Assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy | Biotech Hunter | Biotech Hunter