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

Not Applicable

Recruiting

• Conditions: Cancer of Kidney
• Interventions: Device: valveless trocar; Device: standard trocar

• Registration Number: NCT05732857
• Lead Sponsor: Regina Elena Cancer Institute

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

Study Timeline

• Study First Submitted: 2023-01-30
• Status Verified: 2023-02
• Study Start: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Study First Posted: 2023-02-17
• Last Update Posted: 2023-02-17
• Primary Completion: 2024-01-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

Exclusion Criteria

• BMI>30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute; 🇮🇹 Roma, Italy