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Not yet recruitingNCT07610083Updated Nov 4, 2026

A Study Comparing Single-Port and Multi-Port Robot-Assisted Surgery in Patients With Prostate or Kidney (Renal) Cancer

An observational study in Prostate Cancer and Renal Cancer, sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by IRCCS San Raffaele · Observational

Updated Nov 4, 2026Start date movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
376
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 28 studies in Prostatic Neoplasms by IRCCS San Raffaele — 7 open to participants now, 9 under way, none of them phase 3. Prostatic Neoplasms · IRCCS San Raffaele.

Planned enrollment
7th of 18
376 · median 251
Started
2026
with 1 other
Observational
18 of 28
4 open now
Registered
28th of 28
by date

Among the 28 studies in Prostatic Neoplasms by IRCCS San Raffaele, this one is the 7th largest by planned enrollment of the 18 observational ones, is one of 2 that started in 2026, is one of 18 observational ones, and was the 28th registered.

By phase

28 studies; the count open now beside each. This study's row is marked.

Observationalthis study18 · 4 open
Phase 26 · 2 open
No phase4 · 1 open

By the year they started

First in 2004; this study’s year is marked. 2 started in 2026.

Size and results

Median enrollment 76 across the 10 interventional studies, 251 across the 18 observational. Of the 16 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 28 studies in Prostatic Neoplasms by IRCCS San Raffaele, or all of them as a file.
02

Study summary

This is a prospective single-center observational study comparing single-port (SP) and multi-port (MP) robot-assisted surgery in adult patients undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer.

Consecutive eligible patients will be managed according to routine clinical practice and assigned to SP or MP surgery based on predefined clinical and anatomical criteria, surgeon assessment, patient and tumor characteristics, platform availability, and surgical expertise. No randomization will be performed.

The study aims to compare perioperative outcomes between the two surgical approaches, with length of hospital stay (LOS) as the primary endpoint. Secondary endpoints include intraoperative outcomes (operative time, estimated blood loss, and intraoperative complications), postoperative recovery, pain, postoperative complications, readmission rates, positive surgical margins, and hospital costs.

Functional and patient-reported outcomes will also be evaluated, including urinary continence, sexual function, health-related quality of life, renal function after partial nephrectomy, decision regret, and cosmetic satisfaction.

Read the detailed description

This prospective observational cohort study is conducted at a single high-volume tertiary referral center performing robot-assisted urologic surgery using both single-port (SP) and multi-port (MP) robotic platforms.

The study includes consecutive adult patients (≥18 years) undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer during the study period.

Treatment allocation is not randomized. The choice between SP and MP surgery is made in routine clinical practice by the treating surgeon based on predefined clinical and anatomical criteria, including patient characteristics, tumor features, surgical indication, platform availability, and surgeon experience.

The primary objective is to compare perioperative outcomes between SP and MP robotic-assisted surgery, with length of hospital stay (LOS) defined as the primary endpoint. LOS is measured from the end of surgery (skin closure) to hospital discharge according to standardized discharge criteria.

Secondary outcomes include intraoperative parameters (operative time, estimated blood loss, intraoperative complications), postoperative recovery assessed by validated measures, pain scores, postoperative complications graded by Clavien-Dindo classification, readmission rates, positive surgical margins, and total hospital-related costs.

Additional secondary outcomes include functional outcomes after RARP (urinary continence, sexual function, and health-related quality of life), renal function after RAPN (estimated glomerular filtration rate), decision regret, and cosmetic satisfaction and body image perception.

All outcomes are collected prospectively according to predefined time points within routine follow-up schedules.

03

Conditions studied

  • Prostate Cancer
  • Renal Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male or female participants (≥18 years old) with a diagnosis of prostate or renal cancer candidates for RARP or RAPN.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The participant provides written
  • Male or female participants who are at least 18 years of age on the day of signing informed consent
  • Men with a diagnosis of prostate or renal cancer and women with a diagnosis of renal cancer
  • Pre-operative imaging performed for staging purposes (i.e. CT scan, PSMA PET) showing no suspicious evidence of distant in prostate or renal cancer patients
  • Suitable for RARP or RAPN.

Exclusion criteria

Exclusion Criteria:

  • Patients \< 18 years
  • Mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
  • Inability to read and sign the
  • No available pre-operative staging
  • to surgery
  • Presence of distant (M1)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
376 participants (estimated)
Patient registry
No

Groups and cohorts

  • Single-Port Robot-Assisted Surgery
  • Multi-Port Robot-Assisted Surgery
06

What researchers measure

Primary outcomes

  1. Length of hospital stay (LOS)

    Length of hospital stay (LOS), defined as the time from the end of surgery (skin closure) to hospital discharge, expressed in days or hours. Discharge will be based on predefined and standardized discharge criteria.

    Time frame: Day 30

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.

Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 36 months is below that.

Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 4, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2026
First posted
May 27, 2026
StartEst.
Nov 2026was Oct 2026
Primary completionEst.
Nov 2029
CompletionEst.
Oct 2030
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 2026→Nov 2026
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Start date Oct 2026→Nov 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07610083
Lead sponsor
IRCCS San Raffaele
Responsible party
Francesco Montorsi (Professor and Chairman, IRCCS San Raffaele) — Principal investigator
First posted
May 27, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2029 (estimated)
Completion
Oct 2030 (estimated)
Last update
Nov 4, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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