Comparing back (SARA) versus side (flank) positions for single-port robotic partial kidney tumor removal.
Official title: Standard Flank Approach vs Supine Approach for Robot-assisted Partial Nephrectomy
Run by Niguarda Hospital · NCT07234409 · Data updated 2026-11-12
This will see if placing adults on their back using the SARA technique or on their side leads to fewer complications and faster recovery for people having single-port robotic partial nephrectomy for small kidney tumors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 124 (estimated) |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | October 10, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | March 30, 2027 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07234409 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a single unilateral kidney tumor ≤7 cm (cT1) who are candidates for robot-assisted partial nephrectomy with the Da Vinci SP, without metastatic disease, solitary kidney, prior partial nephrectomy on the same kidney, or end-stage CKD are ideal candidates.
✕Probably not a fit
Patients with multiple or bilateral tumors, tumors larger than 7 cm, metastatic disease, solitary kidney, prior major abdominal conditions that make one approach mandatory, or CKD stage 5 are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center, randomized 1:1 comparison of two patient positions for robot-assisted partial nephrectomy using the Da Vinci Single Port system. Participants with a single unilateral renal mass ≤7 cm will be randomly assigned to either the supine SARA anterior retroperitoneal approach or the standard flank approach. The primary outcome is a composite 'trifecta' of no intraoperative adverse events, negative surgical margins, and discharge on postoperative day 1, with multiple secondary outcomes including pain, time to ambulation, complications within 30 days, operative metrics, and 30-day kidney function. The trial is conducted at ASST Grande Ospedale Metropolitano Niguarda in Milan, Italy.
Why it matters
Potential benefit: If successful, the SARA supine approach could reduce anesthetic and nerve-related risks, shorten hospital stays, and speed recovery while preserving kidney function compared with the standard flank position.
How similar studies have gone: Single-port and supine retroperitoneal techniques have encouraging case series and observational reports, but randomized comparisons like this are relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
* 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)
Where it's running
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ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy Recruiting
Study contacts
- Principal investigator: Paolo Dell'Oglio, MD PhD — ASST Grande Ospedale Metropolitano Niguarda
- Study coordinator: Paolo Dell'Oglio, MD PhD
- Email: paolo.delloglio@ospedaleniguarda.it
- Phone: +393407981232
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.