RecruitingNot ApplicableNCT07234409

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


Sponsor

Niguarda Hospital

Enrollment

124 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different surgical approaches for removing part of a kidney with a tumor using a single-port robotic system, to find out which approach works best for people with early-stage kidney cancer. **You may be eligible if...** - You are 18 or older - You have a single kidney tumor that is 7 cm or smaller, on one side only - The cancer has not spread to lymph nodes or other organs - You are a candidate for robotic-assisted kidney surgery - You have only one kidney tumor (no previous partial kidney removal on the same kidney) **You may NOT be eligible if...** - You only have one working kidney - You have stage 5 chronic kidney disease before surgery - You have had multiple major abdominal surgeries or other conditions that make one approach clearly better than others Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSTANDARD 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.

PROCEDURESupine 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

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NCT07234409


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