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

NCT07234409 | Recruiting DMC

• 1 other identifier: 5448_16.04.2025_N_bis
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Neoplasm

Keywords

kidney cancer; robotic surgery; single port; supine position; full flank position

Outcome Measures

Primary Outcomes (1)

• TRIFECTA

  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

  Intra and perioperative

Secondary Outcomes (2)

• Partial trifecta achievement

  Intra and perioperative

• 30 day complications

  30 postoperative days

Study Arms (2)

GROUP A - STANDARD FLANK APPROACH

OTHER

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.

Other: STANDARD FLANK APPROACH

GROUP B - Supine anterior retroperitoneal approach (SARA).

EXPERIMENTAL

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.

Procedure: Supine anterior retroperitoneal approach (SARA).

Interventions

STANDARD FLANK APPROACH OTHER

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.

GROUP A - STANDARD FLANK APPROACH

Supine anterior retroperitoneal approach (SARA). PROCEDURE

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

GROUP B - Supine anterior retroperitoneal approach (SARA).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Age ≥ 18 years; * Presence of a single, unilateral, primary renal mass ≤ 7 cm in diameter (clinical stage cT1) documented 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 * Absence of solitary kidney status * No previous partial nephrectomy/ies on the same kidney * Absence of preoperative chronic kidney disease (CKD) stage 5 * Absence of any condition that makes mandatory or significantly more adequate the choice of a specific approach over the others (e.g., multiple previous major abdominal surgeries, horseshoe kidney, presence of stomas)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Deception

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Social Behavior; Behavior

Study Officials

• Paolo Dell'Oglio, MD PhD

  ASST Grande Ospedale Metropolitano Niguarda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Dell'Oglio, MD PhD

CONTACT

+393407981232; paolo.delloglio@ospedaleniguarda.it

Stefano Tappero, MD

CONTACT

+393287132369; stefano.tappero@ospedaleniguarda.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

IT (1)