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

February 8, 2023 updated by: Ester Forastiere, MD, Regina Elena Cancer Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00144
        • Recruiting
        • Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute
        • Contact:
        • Contact:
          • Maria Sofra, MD
          • Phone Number: + 39 0652662942
          • Email: sofra@ifo.it
        • Principal Investigator:
          • Marco Covotta, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI>30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: trocar standard
patients in whom the standard trocar will be used to perform robot-assisted complex partial nephrectomy surgery
Device: standard trocar
standard trocar, usually camera port for robotic surgery
Active Comparator: trocar valveless
patients in whom the valveless trocar will be used to perform robot-assisted complex partial nephrectomy surgery
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
Other Names:
  • airseal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: before extubation
before extubation

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative acute pain: using the NRS scale
Time Frame: at 1 hour and at 4 hour after the end of surgery
at 1 hour and at 4 hour after the end of surgery
subcutaneous emphysema: through clinical observation at the end of the intervention
Time Frame: at 30 minutes afetr the end of anesthesia
at 30 minutes afetr the end of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2023

Primary Completion (Anticipated)

January 30, 2024

Study Completion (Anticipated)

January 30, 2025

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1795/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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