Standard Flank Approach vs Supine Approach for Robot-assisted Partial Nephrectomy

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Contact Information
Primary
Paolo Dell'Oglio, MD PhD
paolo.delloglio@ospedaleniguarda.it
+393407981232
Backup
Stefano Tappero, MD
stefano.tappero@ospedaleniguarda.it
+393287132369
Time Frame
Start Date: 2025-10-10
Estimated Completion Date: 2027-03-30
Participants
Target number of participants: 124
Treatments
Other: GROUP A - 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.
Experimental: GROUP B - 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.
Related Therapeutic Areas
Sponsors
Leads: Niguarda Hospital

This content was sourced from clinicaltrials.gov

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