Actively Recruiting
Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure
Led by Elsan · Updated on 2025-07-08
510
Participants Needed
12
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial focuses on men with prostate cancer who are candidates for radical prostatectomy. It aims to compare outpatient versus inpatient robot-assisted radical prostatectomy to determine if managing the procedure as an outpatient leads to similar rates of early post-operative complications. The study evaluates early recovery outcomes and overall patient experience after surgery. Participants will undergo robot-assisted radical prostatectomy either as outpatients or inpatients. The trial compares these two approaches by monitoring early complications from the day of surgery up to eight days afterward. Additional outcomes evaluated include surgery duration, blood loss, recovery of urinary and erectile function, stress and anxiety levels around surgery, patient satisfaction, and longer-term follow-up for up to five years. During the study, participants will visit the clinic at 45 days, 6 months, and annually up to 5 years for check-ups and tests. They will complete surveys on urinary and erectile function, stress, anxiety, satisfaction, and quality of life for six months. Participants are also asked to keep diaries recording treatments and care procedures. Researchers will track hospital readmissions, complications, and economic and social costs related to patient care throughout the follow-up period.
CONDITIONS
Brief Title
Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, aged 18 and over
- Diagnosed with prostate cancer recommended for radical prostatectomy (with or without lymphadenectomy)
- Eligible for outpatient treatment by complying with medical instructions
- Has access to personal transport for return if needed
- Has access to telephone communication
- Will not drive and will be accompanied home and for 24 hours after surgery
- Willing to stay in hospital overnight if doctors decide it is necessary
- Affiliated with or benefiting from a social security scheme
- Provided free, informed, written consent before any research examination
You will not qualify if you...
- Previously treated for prostate cancer with brachytherapy, radiotherapy, or focal therapy
- Participating in another ongoing research or within the exclusion period
- Refuses or cannot comply with the study protocol for any reason
- Under legal protection such as guardianship, curatorship, or deprived of liberty by judicial or administrative decision
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery to 8 days post-operative
Participants undergo robot-assisted radical prostatectomy performed as either an outpatient or inpatient procedure with immediate post-operative monitoring.
1 surgery day visit and daily follow-up visits up to 8 days post-operative
Duration - From 8 days to 6 months post-operative
Participants are followed to monitor complications, recovery of urinary and erectile function, patient satisfaction, and oncological outcomes after surgery.
Visits at 2 days, 45 days, and 6 months post-operative
Duration - From 6 months to 5 years post-operative
Participants are monitored for oncological recurrence, retreatment, and economic and social costs of patient care up to 5 years after surgery.
Periodic visits depending on clinical need up to 5 years post-operative
Trial Site Locations
Total: 12 locations
1
Clinique Rhône Durance
Avignon, France, 84000
Not Yet Recruiting
2
Clinique St Vincent
Besançon, France, 25000
Actively Recruiting
3
Clinique St Augustin
Bordeaux, France, 33074
Actively Recruiting
4
Polyclinique Médipôle St-Roch
Cabestany, France, 66330
Actively Recruiting
5
Polyclinique du Parc
Caen, France, 14000
Not Yet Recruiting
6
Pole Sante Sud-CMCM
Le Mans, France, 72100
Actively Recruiting
7
Hôpital Privé Nancy Lorraine
Nancy, France, 54100
Not Yet Recruiting
8
Polyclinique Les Fleurs
Ollioules, France, 83190
Actively Recruiting
9
Polyclinique Santé Atlantique
Saint-Herblain, France, 44800
Not Yet Recruiting
10
Clinique Belledonne
Saint-Martin-d'Hères, France, 38400
Actively Recruiting
11
Centre clinical
Soyaux, France, 16800
Not Yet Recruiting
12
Hôpital Privé Océane
Vannes, France, 56000
Actively Recruiting
Research Team
C
Charlène PY, Eng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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