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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Study 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

Primary outcome measure(s)

• TRIFECTA — Intra and perioperative
  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

Trial sites (1)

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