RECRUITINGINTERVENTIONAL

Clinical Trial Addressing the Best Surgical Approach for Partial Nephrectomy With Single Port Robotic System in the Management of Localized Renal Cell Carcinoma

Standard Flank Approach vs Supine Approach for Robot-assisted Partial Nephrectomy

About This Trial

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.

Who May Be Eligible (Plain English)

* 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 willing to sign a consent form - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

* 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)

Treatments Being Tested

OTHER

STANDARD FLANK APPROACH

Patients are positioned laterally (on their side) with the operative flank elevated at a 12-15° angle. The Da Vinci SP robotic system is docked either transperitoneally or retroperitoneally through a single access port.

PROCEDURE

Supine anterior retroperitoneal approach (SARA).

Patients are positioned supine with a mild Trendelenburg tilt (0°-10°). A retroperitoneal space is created through an anterior incision, providing direct access to the kidney without repositioning

Locations (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy