Clinical trial · Interventional
Feasibility of Day-surgery Management for Patients Undergoing Robotic Radical Prostatectomy: a Randomized Trial
NCT06891664CI-TRIAL-00113750active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Day surgery regimen for patients | Procedure | — | UNRESOLVED |
| Ordinary management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Day surgery management
- description
- Day-surgery management of patients undergoing robotic radical prostatectomy. It represents a multidisciplinary management that includes nurses, physiotherapists, anesthesiologists and urologists. In addition, patients will be provided with a telemedicine device, to ensure contact between doctor and patient. Patients assigned to the experimental arm will be summoned together with the caregiver the days before the operation to discuss specifically with the nurse, anesthesiologist and urologist the procedure that they will have to follow. At this meeting, the functioning of the telemedicine device will be illustrated.
- interventionNames
- Procedure: Day surgery regimen for patients
- type
- ACTIVE_COMPARATOR
- label
- Ordinary management
- description
- Management of patients undergoing robotic radical prostatectomy in an inpatient setting based on a minimum of two nights of hospitalization.
- interventionNames
- Other: Ordinary management
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.