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NCT06891664
Feasibility of Day-surgery Management for Patients Undergoing Robotic Radical Prostatectomy: a Randomized Trial
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Regina Elena Cancer Institute
Location: "Regina Elena" National Cancer Institute Rome Rome
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 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.
Source: ClinicalTrials.gov (NCT06891664). StuddyBuddy aggregates publicly available trial information.