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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Study 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.

Eligibility

Primary outcome measure(s)

• Study enrollment rate among eligible patients. — 30 months
  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

Trial sites (1)

More Regina Elena Cancer Institute trials in Italy

Other trials for the same condition