Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07234409

Standard Flank Approach vs Supine Anterior Retroperitoneal Approach for Robot-Assisted Partial Nephrectomy Using the Da Vinci SP System

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

124

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating which surgical position is safer and more effective for patients undergoing robot-assisted partial nephrectomy (RAPN), a minimally invasive procedure to remove small kidney tumors while preserving healthy kidney tissue. This trial compares the traditional flank position, where the patient lies on their side, with a newer supine position called the Supine Anterior Retroperitoneal Approach (SARA), where the patient lies on their back. Both procedures use the Da Vinciae Single Port (SP) robotic system to perform surgery through a single small incision. The study focuses on adults with small, localized kidney cancers (tumors 7 cm or less, clinical stage cT1).

CONDITIONS

Brief 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 18 years or older
  • Single, unilateral kidney tumor 7 cm or smaller (clinical stage cT1) confirmed by CT scan
  • No evidence of systemic disease or lymph node involvement
  • Candidate for robot-assisted partial nephrectomy with the Da Vinci SP system
  • Signed informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to hospital discharge on postoperative day 1

Participants undergo robot-assisted partial nephrectomy using either the standard flank approach or the supine anterior retroperitoneal approach (SARA) with the Da Vinci SP system, followed by immediate post-operative care.

1 surgical procedure and hospital stay

Post-operative Follow-up

Duration - 30 days after surgery

Participants are monitored for recovery including pain management, time to first walk and flatus, and assessment of any complications within 30 days after surgery.

Approximately 3 to 4 follow-up visits in 30 days

Trial Site Locations

Total: 1 location

1

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162

Actively Recruiting

Loading map...

Research Team

P

Paolo Dell'Oglio, MD PhD

S

Stefano Tappero, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

German National Registry for Nephron-Sparing Surgery for Loc...

Kidney Neoplasm

Actively Recruiting

5 locations

Study of the Impact of Chronic Renal Failure Stage on Blood ...

Kidney Neoplasm

Actively Recruiting

5 locations

PRE-surgical NEOadjuvant Sandwich Immunotherapy With HIF inh...

Renal Cell Carcinoma

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Clinical protocol for the K-3 trial: a single-center, patient-blinded, randomized clinical trial addressing anesthesiologic, oncological and patient recovery outcomes of standard flank approach vs supine approach for robot-assisted partial nephrectomy.

Stefano Tappero, Sofia Giudici, Elio Mazzone...

https://pubmed.ncbi.nlm.nih.gov/41707608