Perioperative Effects of Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy: a Randomized Prospective Study
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
Ester Forastiere, MD
E Forastiere, MD, Head of Anestesiology and Intensive care Unit
Regina Elena Cancer Institute