Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07234409

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

Led by Niguarda Hospital · Updated on 2025-11-21

124

Participants Needed

1

Research Sites

76 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 18 years
  • Presence of a single, unilateral, primary renal mass 64 7 cm in diameter (clinical stage cT1) documented by CT scan
  • No evidence of systemic disease or lymph node involvement
  • Candidate for robot-assisted partial nephrectomy using the Da Vinci SP platform
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Solitary kidney status
  • Previous partial nephrectomy on the same kidney
  • Preoperative chronic kidney disease (CKD) stage 5
  • Any condition requiring a specific surgical approach over others (e.g., multiple previous major abdominal surgeries, horseshoe kidney, presence of stomas)

AI-Screening

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Trial Site Locations

Total: 1 location

1

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162

Actively Recruiting

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Research Team

P

Paolo Dell'Oglio, MD PhD

CONTACT

S

Stefano Tappero, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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