Comparing back (SARA) versus side (flank) positions for single-port robotic partial kidney tumor removal.
Standard Flank Approach vs Supine Approach for Robot-assisted Partial Nephrectomy
NA · Niguarda Hospital · NCT07234409
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Niguarda Hospital (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT07234409 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Single-port and supine retroperitoneal techniques have encouraging case series and observational reports, but randomized comparisons like this are relatively novel.
Eligibility criteria
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 this trial is running
Milan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Neoplasm, kidney cancer, robotic surgery, single port, supine position, full flank position