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NCT06891664Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 5 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
17 Mar 2025
Start date
23 Oct 2024
Primary completion date
23 May 2027
Lead sponsor
Regina Elena Cancer Institute
NCT number
NCT06891664

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 23 Oct 2024 to the primary completion date, 23 May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • second simultaneous surgery;
  • patients receiving anticoagulants or oral antiplatelet drugs;
  • other concomitant tumors undergoing treatment;
  • previous pelvic radiotherapy;
  • previous surgery for benign prostatic hypertrophy;
  • patients not suitable for a day-surgery approach based on the clinical evaluation of the operating surgeons and anesthetists.

Age

  • patients \> 75 years of age;

Other

  • ASA \> 2;
  • prostate volume \> 80 cc estimated on preoperative imaging (transrectal ultrasound or magnetic resonance imaging);
  • patients lacking the digital literacy required to take advantage of telemedicine intervention;
  • patients who cannot benefit from at least one caregiver;

Who the study is looking for

  • 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).

Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Regina Elena National Cancer Institute
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.