Feasibility of Day-surgery Management for Patients Undergoing Robotic Radical Prostatectomy: a Ra… (NCT06891664) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Feasibility of Day-surgery Management for Patients Undergoing Robotic Radical Prostatectomy: a Randomized Trial
Italy90 participantsStarted 2024-10-23
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hyper…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.