CLamp vs Off Clamp Kidney During Partial Nephrectomy
Not Applicable
- Conditions
- Glomerular Filtration RateNephrectomyKidney Neoplasm
- Registration Number
- NCT02287987
- Brief Summary
Prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- normal coagulation trim
- pre operative Glomerular Filtration Rate (GFR) > 60 ml/min
- healty contralateral kidney
- low (4-6) or intermediate (7-10) RENAL score
- availability of Da Vinci Robotic System
Exclusion Criteria
- altered coagulation trim
- pre operative Glomerular Filtration Rate (GFR) < 60 ml/min
- anatomic or functional solitary kidney
- RENAL score >10
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Glomerular Filtration Rate (GFR) variation 3-6 months difference between pre and post operative Glomerular Filtration Rate (GFR)
- Secondary Outcome Measures
Name Time Method Feasibility of clampless robotic partial nephrectomy Duration of the surgical procedure number of cases shifted from clampless to clamping procedure; time of suture of the renal parenchyma; overall operative time.
Morbidity of clampless robotic partial nephrectomy 90 days Estimated blood loss; pre/post operative variation of hemoglobin value; overall complications rate; bleeding complications rate
Oncological safety of clampless robotic partial nephrectomy 15 days positive surgical margins rate
Trial Locations
- Locations (1)
Clinical Department of Urology, university Hospital Spedali Civili di Brescia
🇮🇹Brescia, Italy
Clinical Department of Urology, university Hospital Spedali Civili di Brescia🇮🇹Brescia, Italy