Actively Recruiting
Clinical Trial Addressing the Best Surgical Approach for Partial Nephrectomy With Single Port Robotic System in the Management of Localized Renal Cell Carcinoma
Led by Niguarda Hospital · Updated on 2025-11-21
124
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to find out which surgical position is safer and works better for patients candidate to robot-assisted partial nephrectomy (RAPN) - a minimally invasive procedure to remove a small kidney tumor while preserving healthy kidney tissue. During this operation, the patient can be placed in two different positions: * the standard flank position, where the patient lies on their side * a newer supine position, where the patient lies on their back using a technique called Supine Anterior Retroperitoneal Approach (SARA). Both approaches are performed using the Da Vinci® Single Port (SP) robotic system, a state-of-the-art surgical robot that allows the operation to be done through a single small incision. The traditional flank position has been used for many years, but it can be uncomfortable for patients and may increase the risk of certain anesthetic or nerve-related complications, especially in people with higher body weight. The new supine SARA technique could make surgery faster, safer, and less painful, but it has not yet been tested in a randomized study. This is the first clinical trial designed to directly compare these two approaches in patients with small and localized kidney cancers (tumors ≤7 cm, stage cT1). The study will include 124 patients treated at ASST Grande Ospedale Metropolitano Niguarda in Milan, Italy - a leading center in robotic urologic surgery.
CONDITIONS
Official Title
Clinical Trial Addressing the Best Surgical Approach for Partial Nephrectomy With Single Port Robotic System in the Management of Localized Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Presence of a single, unilateral, primary renal mass 64 7 cm in diameter (clinical stage cT1) documented by CT scan
- No evidence of systemic disease or lymph node involvement
- Candidate for robot-assisted partial nephrectomy using the Da Vinci SP platform
- Signed informed consent
You will not qualify if you...
- Solitary kidney status
- Previous partial nephrectomy on the same kidney
- Preoperative chronic kidney disease (CKD) stage 5
- Any condition requiring a specific surgical approach over others (e.g., multiple previous major abdominal surgeries, horseshoe kidney, presence of stomas)
AI-Screening
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Trial Site Locations
Total: 1 location
1
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
Research Team
P
Paolo Dell'Oglio, MD PhD
CONTACT
S
Stefano Tappero, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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