Clinical Trial Addressing the Best Surgical Approach for Partial Nephrectomy With Single Port Robotic System in the Management of Localized Renal Cell Carcinoma
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
* Age ≥ 18 years; * Presence of a single, unilateral, primary renal mass ≤ 7 cm in diameter (clinical stage cT1) documented 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 * Absence of solitary kidney status * No previous partial nephrectomy/ies on the same kidney * Absence of preoperative chronic kidney disease (CKD) stage 5 * Absence of any condition that makes mandatory or significantly more adequate the choice of a specific approach over the others (e.g., multiple previous major abdominal surgeries, horseshoe kidney, presence of stomas)