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

NCT06891664 | Active Not Recruiting

• 1 other identifier: RS254/IRE/24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Study enrollment rate among eligible patients.

  RCT (randomized controlled trial) enrollment measured as the relative frequency percentage of patients who meet the eligibility criteria and agree to participate in the proposed trial (numerator), divided by the number of all eligible patients in the recruitment period (denominator). Patients who withdraw consent before knowing the outcome of randomization will be counted as having refused participation. The expected result is an enrollment rate of at least 30%. Therefore, the primary objective will be considered achieved if at least 30% of eligible patients agree to participate in the aforementioned trial

  30 months

Secondary Outcomes (1)

• Study Retention Rate

  30 months

Study Arms (2)

Day surgery management

EXPERIMENTAL

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.

Procedure: Day surgery regimen for patients

Ordinary management

ACTIVE COMPARATOR

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

Other: Ordinary management

Interventions

Day surgery regimen for patients 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.

Day surgery management

Ordinary management OTHER

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

Ordinary management

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Costantino Leonardo, Doctor

  IRCCS National Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 24, 2025
• Study Start: October 23, 2024
• Primary Completion (Estimated): May 23, 2027
• Study Completion (Estimated): May 23, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

IT (1)