Status:
ACTIVE_NOT_RECRUITING
Feasibility of Day-surgery Management for Patients Undergoing Robotic Radical Prostatectomy: a Randomized Trial
Lead Sponsor:
Regina Elena Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 23 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06891664
Start Date
October 23 2024
End Date
May 23 2027
Last Update
March 24 2025
Active Locations (1)
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1
"Regina Elena" National Cancer Institute
Rome, Italy, 00144