Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
Condition(s) studied
Investigational drug(s) / intervention(s)
radical prostatectomy: Robot-assisted
Study 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
Eligibility
Primary outcome measure(s)
- Early complication of robot-assisted prostatectomy — From the day of surgery to 8 days post-operative
The occurrence (yes/no) of at least one early complication of robot-assisted prostatectomy. The early clinical complications expected are : * Bleeding from trocar incision scars or surgical excision scars * Urinary leakage around the catheter * Retention due to bladder catheter clotting * Loss of bladder catheter * Signs of internal haemorrhage (within 24 hours) * Signs of biological deglobulation * Intestinal obstruction syndrome * Signs of urinary fistula * Infectious signs : fever \> 38°, chills * Thromboembolicaccidents * Nosocomial infections * Falls
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinique Rhône Durance | Avignon | France | Not Yet Recruiting |
| Clinique St Vincent | Besançon | France | Recruiting |
| Clinique St Augustin | Bordeaux | France | Recruiting |
| Polyclinique Médipôle St-Roch | Cabestany | France | Recruiting |
| Polyclinique du Parc | Caen | France | Not Yet Recruiting |
| Pole Sante Sud-CMCM | Le Mans | France | Recruiting |
| Hôpital Privé Nancy Lorraine | Nancy | France | Not Yet Recruiting |
| Polyclinique Les Fleurs | Ollioules | France | Recruiting |
| Polyclinique Santé Atlantique | Saint-Herblain | France | Not Yet Recruiting |
| Clinique Belledonne | Saint-Martin-d'Hères | France | Recruiting |
| Centre clinical | Soyaux | France | Not Yet Recruiting |
| Hôpital Privé Océane | Vannes | France | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06822452 on ClinicalTrials.gov ↗ ← All trials in France