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.
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;
None
Sequential
STANDARD FLANK APPROACH
Other interventionPatients 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.
Supine anterior retroperitoneal approach (SARA).
Procedure/SurgeryPatients 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
TRIFECTA
Trifecta is defined as the coexistence of these three conditions: 1. Absence of any intraoperative adverse event 2. Absence of positive surgical margins 3. Hospital discharge at postoperative day 1
Partial trifecta achievement
Secondary end point of the study is to compare RAPN performed with the SARA approach vs RAPN performed with standard flank approach according to the rate of achievement of two out of three outcomes, and lastly according to each outcome composing the trifecta separately.
30 day complications
complications
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