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

Perioperative Effects of Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy: a Randomized Prospective Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05732857

Enrollment

Registered

2023-02-17

Start date

2023-02-08

Completion date

2025-01-30

Last updated

2023-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Kidney

Keywords

robotic nephrectomy, pneumoperitoneum, trocar valveless, general anesthesia, mechanical ventilation

Brief 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

Interventions

DEVICEvalveless trocar

the valveless trocar will be used instead of the standard trocar - these trocars are used for insufflation of carbon dioxide into the abdomen

DEVICEstandard trocar

standard trocar, usually camera port for robotic surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

control arm: patients in which traditional laparoscopic trocar is used intervention arm: patients in which the valveless trocar is used

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* BMI\>30

Design outcomes

Primary

Measure	Time frame
carbon dioxide elimination rate: using the formula where end tidal carbon dioxide multiplied by minute volume divided by arterial pressurea (760mmHg) multiplied by patient weight	before extubation

Secondary

Measure	Time frame
postoperative acute pain: using the NRS scale	at 1 hour and at 4 hour after the end of surgery
subcutaneous emphysema: through clinical observation at the end of the intervention	at 30 minutes afetr the end of anesthesia

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026