Clinical Trial

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

Study acronym: K3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-14.
Trial Details
NCT Number NCT07234409
Lead Sponsor Niguarda Hospital
Conditions Kidney Neoplasm
Enrollment 124 participants
Start Date 2025-10-10
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-21