Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Cancer of Kidney

Treatments: Device: valveless trocar; Device: standard trocar

Study type: Interventional

Funder types: Other

Identifiers

NCT05732857

1795/22

Details and patient eligibility

About

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.

Full 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

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• asa status 1-3
• surgical classification RENAL or PADUA score >9

Exclusion criteria

• BMI>30

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

trocar standard

Sham Comparator group

Description:

patients in whom the standard trocar will be used to perform robot-assisted complex partial nephrectomy surgery

Treatment:

Device: standard trocar

trocar valveless

Active Comparator group

Description:

patients in whom the valveless trocar will be used to perform robot-assisted complex partial nephrectomy surgery

Treatment:

Device: valveless trocar