Comparing Side-Lying and Back-Lying Surgical Positions for Robot-Assisted Partial Kidney Tumor Removal Using the Da Vinci Single Port System
Led by Niguarda Hospital · Updated on 2025-11-21
124
Participants Needed
1
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating which surgical position is safer and more effective for patients undergoing robot-assisted partial nephrectomy RAPN, a minimally invasive procedure to remove small kidney tumors while preserving healthy kidney tissue. This trial compares the traditional flank position, where the patient lies on their side, with a newer supine position called the Supine Anterior Retroperitoneal Approach SARA, where the patient lies on their back. Both procedures use the Da Vinciae Single Port SP robotic system to perform surgery through a single small incision. The study focuses on adults with small, localized kidney cancers tumors 7 cm or less, clinical stage cT1.
CONDITIONS
Brief Title
Clinical Trial Addressing the Best Surgical Approach for Partial Nephrectomy With Single Port Robotic System in the Management of Localized Renal Cell Carcinoma
Research Team
P
Paolo Dell'Oglio, MD PhD
S
Stefano Tappero, MD
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Single, unilateral kidney tumor 7 cm or smaller (clinical stage cT1) confirmed by CT scan
No evidence of systemic disease or lymph node involvement
Candidate for robot-assisted partial nephrectomy with the Da Vinci SP system
Signed informed consent
You will not qualify if you...
Solitary kidney status
Previous partial nephrectomy on the same kidney
Chronic kidney disease stage 5 before surgery
Any condition requiring a specific surgical approach over others (e.g., multiple major abdominal surgeries, horseshoe kidney, presence of stomas)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to hospital discharge on postoperative day 1
Participants undergo robot-assisted partial nephrectomy using either the standard flank approach or the supine anterior retroperitoneal approach (SARA) with the Da Vinci SP system, followed by immediate post-operative care.
1 surgical procedure and hospital stay
Post-operative Follow-up
Duration - 30 days after surgery
Participants are monitored for recovery including pain management, time to first walk and flatus, and assessment of any complications within 30 days after surgery.
Approximately 3 to 4 follow-up visits in 30 days
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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Published Research Related To This Trial
Clinical protocol for the K-3 trial: a single-center, patient-blinded, randomized clinical trial addressing anesthesiologic, oncological and patient recovery outcomes of standard flank approach vs supine approach for robot-assisted partial nephrectomy.