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Trial Title:
Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy
NCT ID:
NCT05732857
Condition:
Cancer of Kidney
Conditions: Official terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Conditions: Keywords:
robotic nephrectomy
pneumoperitoneum
trocar valveless
general anesthesia
mechanical ventilation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
control arm: patients in which traditional laparoscopic trocar is used intervention arm:
patients in which the valveless trocar is used
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
valveless trocar
Description:
the valveless trocar will be used instead of the standard trocar - these trocars are used
for insufflation of carbon dioxide into the abdomen
Arm group label:
trocar valveless
Other name:
airseal
Intervention type:
Device
Intervention name:
standard trocar
Description:
standard trocar, usually camera port for robotic surgery
Arm group label:
trocar standard
Summary:
The goal of this clinical trial is to compare two kind of trocar in patients undergoing
complex robot-assisted partial nephrectomy. The main question it intends to answer is
whether the use of valveless trocars can significantly reduce carbon dioxide absorption.
Detailed description:
In the literature there are studies on the benefit of valveless trocars in robotic
surgery. There are no studies on the potential effects even in complex kidney surgery.
Through this randomized study we want to investigate whether the ability to clear CO2 is
better using valveless trocars
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- asa status 1-3
- surgical classification RENAL or PADUA score >9
Exclusion Criteria:
- BMI>30
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ester Forastiere, MD
Phone:
0652662942
Phone ext:
+ 39
Email:
forastiere@ifo.it
Contact backup:
Last name:
Maria Sofra, MD
Phone:
0652662942
Phone ext:
+ 39
Email:
sofra@ifo.it
Investigator:
Last name:
Marco Covotta, MD
Email:
Principal Investigator
Start date:
February 8, 2023
Completion date:
January 30, 2025
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05732857
