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

Primary Purpose

Cancer of Kidney

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

valveless trocar

standard trocar

About this trial

This is an interventional treatment trial for Cancer of Kidney focused on measuring robotic nephrectomy, pneumoperitoneum, trocar valveless, general anesthesia, mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Anaesthesiology, IRCCS Regina Elena National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

trocar standard

trocar valveless

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

postoperative acute pain: using the NRS scale

subcutaneous emphysema: through clinical observation at the end of the intervention

Full Information

NCT ID

NCT05732857

First Posted

January 30, 2023

Last Updated

February 8, 2023

Sponsor

Regina Elena Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT05732857

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 8, 2023 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Regina Elena Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of Kidney

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

trocar standard

Arm Type

Sham Comparator

Arm Description

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

Arm Title

trocar valveless

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

valveless trocar

Other Intervention Name(s)

airseal

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

standard trocar

Intervention Description

standard trocar, usually camera port for robotic surgery

Primary Outcome Measure Information:

Title

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

Time Frame

before extubation

Secondary Outcome Measure Information:

Title

postoperative acute pain: using the NRS scale

Time Frame

at 1 hour and at 4 hour after the end of surgery

Title

subcutaneous emphysema: through clinical observation at the end of the intervention

Time Frame

at 30 minutes afetr the end of anesthesia

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute

City

Roma

ZIP/Postal Code

00144

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ester Forastiere, MD

Phone

0652662942

Ext

+ 39

forastiere@ifo.it

First Name & Middle Initial & Last Name & Degree

Maria Sofra, MD

Phone

0652662942

Ext

+ 39

sofra@ifo.it

First Name & Middle Initial & Last Name & Degree

Marco Covotta, MD

12. IPD Sharing Statement

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

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