Kidney NeoplasmK3NCT07234409
Clinical Trial Addressing the Best Surgical Approach for Partial Nephrectomy With Single Port Robotic System in the Management of Localized Renal Cell Carcinoma
A study testing STANDARD FLANK APPROACH and Supine anterior retroperitoneal approach (SARA). in people with Kidney Neoplasm, run by Niguarda Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasm
- What is being tested?
- STANDARD FLANK APPROACH and Supine anterior retroperitoneal approach (SARA).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Paolo Dell'Oglio, MD PhD, +393407981232, paolo.delloglio@ospedaleniguarda.it
Stefano Tappero, MD, +393287132369 ext. +390264447896, stefano.tappero@ospedaleniguarda.it
About this study
Official title: Standard Flank Approach vs Supine Approach for Robot-assisted Partial Nephrectomy
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:
Read more
- 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.
Read the detailed description
Study Objectives
Primary Objective:
To compare the outcomes of RAPN performed with the SARA approach versus the standard flank approach in achieving a "trifecta outcome," defined as:
- No intraoperative adverse events;
- Negative (cancer-free) surgical margins;
- Hospital discharge on postoperative day 1.
Secondary Objectives:
- To compare both approaches according to the rate of achievement of two out of three outcomes, and according to each outcome composing the trifecta separately.
- To evaluate postoperative recovery, including pain scores, time to first walk, time to first flatus, total use of pain medication, and readiness for discharge.
- To compare the rates and severity of postoperative complications within 30 days after surgery.
- To assess surgical parameters such as total operative time, ischemia time, and blood loss.
- To analyze functional outcomes, such as kidney function recovery (Δ eGFR at 30 days).
Study Design This is a prospective, single-center, randomized controlled trial conducted at the Department of Urology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Eligible participants will be randomly assigned 1:1 to one of two groups:
Group A (Control): Standard flank approach (transperitoneal or retroperitoneal) using the Da Vinci SP system. 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. The tumor is resected and kidney reconstruction is performed according to standard RAPN procedures Group B (Experimental): Supine anterior retroperitoneal approach (SARA) using the Da Vinci SP system. 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. The same Da Vinci SP system and standard nephron-sparing techniques are used.
Both groups follow identical perioperative protocols for anesthesia, analgesia, and postoperative care.
Population Adults (age 18 or older) with a single kidney tumor measuring up to 7 cm, who are eligible for robotic partial nephrectomy with the Da Vinci SP system, may be invited to participate. Patients with kidney tumor more than 7 cm or advanced tumors infiltrating the surroinding tissues, solitary kidneys, previous kidney surgery on the same kidney, or severe kidney disease will not be eligible.
- Conditions
- Kidney Neoplasm
- Being tested
- STANDARD FLANK APPROACH, Supine anterior retroperitoneal approach (SARA).
- Keywords
- kidney cancer, robotic surgery, single port, supine position, full flank position
- Medical subject headings
- Kidney Neoplasms, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STANDARD FLANK APPROACHOther
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.
Supine anterior retroperitoneal approach (SARA).Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Supine anterior retroperitoneal approach (SARA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRIFECTA
Trifecta is defined as the coexistence of these three conditions:
- Absence of any intraoperative adverse event
- Absence of positive surgical margins
- Hospital discharge at postoperative day 1
Measured: Intra and perioperative
Secondary outcomes (2)
Partial trifecta achievement
Secondary end point of the study is to compare RAPN performed with the SARA approach vs RAPN performed with standard flank approach according to the rate of achievement of two out of three outcomes, and lastly according to each outcome composing the trifecta separately.
Measured: Intra and perioperative
30 day complications
complications
Measured: 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start10 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Dell'Oglio, MD PhD, Principal investigator, ASST Grande Ospedale Metropolitano Niguarda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234409
- Sponsor's protocol ID
- 5448_16.04.2025_N_bis
- Acronym
- K3
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tappero S, Giudici S, Mazzone E, Caviglia A, Cellini V, Natoli R, Pettenuzzo D, Mulazzani F, Gianni S, Antonucci E, Colombo J, Torrano V, Nizzardo M, Quistini A, Colombo M, Barbieri M, Napoli G, Buratto C, Palagonia E, Olivero A, Secco S, Petralia G, Strada E, Di Trapani D, Monti G, Bocciardi AM, Galfano A, Dell'Oglio P. 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. Surg Oncol. 2026 Apr;65:102370. doi: 10.1016/j.suronc.2026.102370. Epub 2026 Feb 13.
PubMed 41707608
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Flank Approach vs Supine Approach for Robot-assisted Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT07234409
- Acronym / sponsor ID
- K3 / 5448_16.04.2025_N_bis
- Conditions
- Kidney Neoplasm
- Keywords
- kidney cancer, robotic surgery, single port, supine position, full flank position
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Objectives
Primary Objective:
To compare the outcomes of RAPN performed with the SARA approach versus the standard flank approach in achieving a "trifecta outcome," defined as:
- No intraoperative adverse events;
- Negative (cancer-free) surgical margins;
- Hospital discharge on postoperative day 1.
Secondary Objectives:
- To compare both approaches according to the rate of achievement of two out of three outcomes, and according to each outcome composing the trifecta separately.
- To evaluate postoperative recovery, including pain scores, time to first walk, time to first flatus, total use of pain medication, and readiness for discharge.
- To compare the rates and severity of postoperative complications within 30 days after surgery.
- To assess surgical parameters such as total operative time, ischemia time, and blood loss.
- To analyze functional outcomes, such as kidney function recovery (Δ eGFR at 30 days).
Study Design This is a prospective, single-center, randomized controlled trial conducted at the Department of Urology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Eligible participants will be randomly assigned 1:1 to one of two groups:
Group A (Control): Standard flank approach (transperitoneal or retroperitoneal) using the Da Vinci SP system. 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. The tumor is resected and kidney reconstruction is performed according to standard RAPN procedures Group B (Experimental): Supine anterior retroperitoneal approach (SARA) using the Da Vinci SP system. 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. The same Da Vinci SP system and standard nephron-sparing techniques are used.
Both groups follow identical perioperative protocols for anesthesia, analgesia, and postoperative care.
Population Adults (age 18 or older) with a single kidney tumor measuring up to 7 cm, who are eligible for robotic partial nephrectomy with the Da Vinci SP system, may be invited to participate. Patients with kidney tumor more than 7 cm or advanced tumors infiltrating the surroinding tissues, solitary kidneys, previous kidney surgery on the same kidney, or severe kidney disease will not be eligible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A - STANDARD FLANK APPROACH | Other | Other: STANDARD FLANK APPROACHPatients 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 B - Supine anterior retroperitoneal approach (SARA). | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STANDARD FLANK APPROACHPatients 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 | GROUP A - STANDARD FLANK APPROACH |
| 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 | Procedure or surgery | GROUP B - Supine anterior retroperitoneal approach (SARA). |
Primary outcome
TRIFECTA
Time frame: Intra and perioperative
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
2 secondary outcomes
Partial trifecta achievement
Time frame: Intra and perioperative
30 day complications
Time frame: 30 postoperative days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 41707608Tappero S, Giudici S, Mazzone E, Caviglia A, Cellini V, Natoli R, Pettenuzzo D, Mulazzani F, Gianni S, Antonucci E, Colombo J, Torrano V, Nizzardo M, Quistini A, Colombo M, Barbieri M, Napoli G, Buratto C, Palagonia E, Olivero A, Secco S, Petralia G, Strada E, Di Trapani D, Monti G, Bocciardi AM, Galfano A, Dell'Oglio P. 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. Surg Oncol. 2026 Apr;65:102370. doi: 10.1016/j.suronc.2026.102370. Epub 2026 Feb 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo Dell'Oglio, MD PhD principal investigator
ASST Grande Ospedale Metropolitano Niguarda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STANDARD FLANK APPROACH and Supine anterior retroperitoneal approach (SARA). in people with Kidney Neoplasm, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Dell'Oglio, MD PhD (+393407981232, paolo.delloglio@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRIFECTA (time frame: Intra and perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07234409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.