Feasibility of Day-surgery Management for Patients Undergoing Robotic Radical Prostatectomy: a Randomized Trial

NCT ID: NCT06891664

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-23
• Study Completion Date: 2027-05-23

Brief Summary

To compare the day-surgery approach versus routine management in patients undergoing robotic radical prostatectomy, aimed at evaluating the feasibility of a one-day hospitalization regimen for robotic radical prostatectomy.

The study will allow to evaluate the patients'compliance and subsequently investigate the safety, the impact on the patient's quality of life and on the healthcare costs resulting from day-surgery management of patients undergoing robotic radical prostatectomy.

Detailed Description

The clinical study is aimed at evaluating the compliance of patients, candidates for robot-assisted radical prostatectomy for prostate cancer, to be enrolled in an RCT that provides for assignment to day surgery management (experimental arm) or ordinary management (control arm). The study involves the evaluation of the compliance of patients, candidates for robot-assisted radical prostatectomy for prostate cancer, to be enrolled in an RCT that provides for assignment to day surgery management (experimental arm) or ordinary management (control arm).

The study will allow us to test a protocol for day-surgery management that includes all the clinical and technological measures at our disposal, including single-port robotic surgery and telemedicine. Using the experience and results obtained from this trial, it will then be possible to design a confirmatory multicenter RCT that compares day-surgery management vs ordinary management. The latter will then have the task of demonstrating with a high level of evidence that robotic radical prostatectomy can be performed safely in day-surgery, guaranteeing economic advantages to the facility while also favoring a more rapid recovery of the patient. Considering that approximately 20,000 radical prostatectomies are performed every year in Italy, this paradigm shift could guarantee a significant economic advantage. A transition of this type requires robust scientific evidence in order to convince doctors, patients and health systems to rely on a more efficient health model based on better management of resources.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Day surgery management

Day-surgery management of patients undergoing robotic radical prostatectomy. It represents a multidisciplinary management that includes nurses, physiotherapists, anesthesiologists and urologists. In addition, patients will be provided with a telemedicine device, to ensure contact between doctor and patient.

Patients assigned to the experimental arm will be summoned together with the caregiver the days before the operation to discuss specifically with the nurse, anesthesiologist and urologist the procedure that they will have to follow. At this meeting, the functioning of the telemedicine device will be illustrated.

Group Type: EXPERIMENTAL

Day surgery regimen for patients

Intervention Type: PROCEDURE

The protocol includes admission on the evening of Day -1 and the execution of the surgery on the morning of Day 0 under general anesthesia. The surgery will be performed with the aid of the Da Vinci Single-port robotic system with extraperitoneal access.

Ordinary management

Management of patients undergoing robotic radical prostatectomy in an inpatient setting based on a minimum of two nights of hospitalization.

Group Type: ACTIVE_COMPARATOR

Ordinary management

Intervention Type: OTHER

Management of patients undergoing robotic radical prostatectomy in an inpatient setting based on a minimum of two nights of hospitalization

Interventions

Day surgery regimen for patients

The protocol includes admission on the evening of Day -1 and the execution of the surgery on the morning of Day 0 under general anesthesia. The surgery will be performed with the aid of the Da Vinci Single-port robotic system with extraperitoneal access.

Intervention Type: PROCEDURE

Ordinary management

Management of patients undergoing robotic radical prostatectomy in an inpatient setting based on a minimum of two nights of hospitalization

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients with localized prostate adenocarcinoma at low-intermediate risk (EAU Risk classification);
• patients aged >= 18 years;
• patients with an indication to undergo robotic radical prostatectomy without lymphadenectomy according to the EAU guidelines;
• patients who agree to undergo robotic radical prostatectomy without lymphadenectomy according to the EAU guidelines by signing a written informed consent;
• patients eligible for robotic radical prostatectomy without lymphadenectomy and in the absence of contraindications to undergo the procedure;
• patient's ability to understand and willingness to sign a written informed consent indicating that he has understood the purpose and methods of conducting the study and is interested in participating.;
• patients able to follow the indications specified in the study protocol;
• patients domiciled (even temporarily) < 150 km away from the institution where the procedure will be performed;
• patients domiciled (even temporarily) < 60 minutes by car from a reference Emergency and Acceptance Department (DEA).

Exclusion Criteria

• patients > 75 years of age;
• ASA > 2;
• second simultaneous surgery;
• prostate volume > 80 cc estimated on preoperative imaging (transrectal ultrasound or magnetic resonance imaging);
• patients receiving anticoagulants or oral antiplatelet drugs;
• other concomitant tumors undergoing treatment;
• previous pelvic radiotherapy;
• previous surgery for benign prostatic hypertrophy;
• patients lacking the digital literacy required to take advantage of telemedicine intervention;
• patients who cannot benefit from at least one caregiver;
• patients not suitable for a day-surgery approach based on the clinical evaluation of the operating surgeons and anesthetists.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Costantino Leonardo, Doctor

Role: PRINCIPAL_INVESTIGATOR

IRCCS National Cancer Institute

Locations

"Regina Elena" National Cancer Institute

Rome, , Italy

Countries

Italy

Other Identifiers

RS254/IRE/24

Identifier Type: -

Identifier Source: org_study_id