A Study Comparing Single-Port and Multi-Port Robot-Assisted Surgery in Patients With Prostate or Kidney (Renal) Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Male or female participants (≥18 years old) with a diagnosis of prostate or renal cancer candidates for RARP or RAPN.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
376 Participants
are grouped into 2 trial groupsGroup A: Single-Port Robot-Assisted Surgery
Group B: Multi-Port Robot-Assisted Surgery
Trial outcomes
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 30Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: