A Study Comparing Single-Port and Multi-Port Robot-Assisted Surgery in Patients With Prostate or Kidney (Renal) Cancer
Single-port vs. Multi-port Robot-assisted Surgery for Prostate or Renal Cancer
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
-
-
-
Milan, Italien, 20132
- IRCCS Ospedale San Raffaele
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- The participant provides written informed consent
- 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 metastases in prostate or renal cancer patients
- Suitable for RARP or RAPN.
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 informed consent
- No available pre-operative staging
- Contraindication to surgery
- Presence of distant metastases (M1)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Single-Port Robot-Assisted Surgery
|
|
Multi-Port Robot-Assisted Surgery
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Length of hospital stay (LOS)
Tidsramme: Day 30
|
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.
|
Day 30
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Urologiske neoplasmer
- Prostatiske neoplasmer
- Nyre-neoplasmer
Andre undersøgelses-id-numre
- PORTAL Study
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .