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RECRUITING
NCT07234409
NA

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

Sponsor: Niguarda Hospital

View on ClinicalTrials.gov

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.

Official title: Standard Flank Approach vs Supine Approach for Robot-assisted Partial Nephrectomy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-10-10

Completion Date

2027-03-30

Last Updated

2025-11-21

Healthy Volunteers

No

Conditions

Interventions

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