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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Cancer of Kidney

Intervention / Treatment
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* Device: valveless trocar
* Device: standard trocar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: asa status 1-3 surgical classification RENAL or PADUA score >9 Exclusion Criteria: BMI>30

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control arm: patients in which traditional laparoscopic trocar is used intervention arm: patients in which the valveless trocar is used
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: trocar standard<br>patients in whom the standard trocar will be used to perform robot-assisted complex partial nephrectomy surgery | Device: standard trocar<br>* standard trocar, usually camera port for robotic surgery<br>|
| Active Comparator: trocar valveless<br>patients in whom the valveless trocar will be used to perform robot-assisted complex partial nephrectomy surgery | Device: valveless trocar<br>* the valveless trocar will be used instead of the standard trocar - these trocars are used for insufflation of carbon dioxide into the abdomen<br>* Other names: airseal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic nephrectomy, pneumoperitoneum, trocar valveless, general anesthesia, mechanical ventilation