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

NCT ID: NCT05732857

Last Updated: 2023-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2025-01-30

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

Conditions

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Cancer of Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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trocar standard

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

Group Type SHAM_COMPARATOR

standard trocar

Intervention Type DEVICE

standard trocar, usually camera port for robotic surgery

trocar valveless

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

Group Type ACTIVE_COMPARATOR

valveless trocar

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

standard trocar

standard trocar, usually camera port for robotic surgery

Intervention Type DEVICE

Other Intervention Names

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airseal

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* BMI\>30
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Ester Forastiere, MD

E Forastiere, MD, Head of Anestesiology and Intensive care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Ester Forastiere, MD

Role: primary

0652662942 ext. + 39

Maria Sofra, MD

Role: backup

0652662942 ext. + 39

Other Identifiers

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1795/22

Identifier Type: -

Identifier Source: org_study_id

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