Clinical Trial

Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.

Study acronym: PROSTAMBU
Recruiting
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Summary
The goal of this clinical trial is to demonstrate that outpatient management for robotic-assisted radical prostatectomy is not inferior to inpatient management in terms of the occurrence of early post-operative complications. Researchers will compare outpatient robot-assisted radical prostatectomy to inpatient procedure. Participants will: * Visit the clinic after the operation once at 45 days, 6 months and once a year for up to 5 years for check-ups and tests. * Answer survey questions about urinary and erectil functions, stress and anxiety, satisfaction, quality of life for 6 months * Keep a diary to record procedures and treatments related to the care provided
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-06.
Trial Details
NCT Number NCT06822452
Lead Sponsor Elsan
Conditions Prostate Cancer Surgery, Ambulatory Care, Outpatient Surgery
Enrollment 510 participants
Start Date 2024-12-30
Primary Completion 2027-01-07 (estimated)
Study Completion 2030-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-08