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

Cancer of Kidney Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05732857
• Other study ID #: 1795/22
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: February 2023
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• asa status 1-3

• surgical classification RENAL or PADUA score >9

Exclusion Criteria:

• BMI>30

Related Conditions & MeSH terms

• Cancer of Kidney
• Carcinoma, Renal Cell
• Kidney Neoplasms

Intervention

Device:
• valveless trocar
the valveless trocar will be used instead of the standard trocar - these trocars are used for insufflation of carbon dioxide into the abdomen
• standard trocar
standard trocar, usually camera port for robotic surgery

Locations

Country	Name	City	State
Italy	Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

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