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Clinical Trials/NCT05732857
NCT05732857RecruitingNot Applicable

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

Regina Elena Cancer Institute2 sites in 1 country66 target enrollmentStarted: February 8, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
66
Locations
2
Primary Endpoint
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

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ester Forastiere, MD

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

Regina Elena Cancer Institute

Study Sites (2)

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