Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
Recruiting now · Not applicable
Conditions studied: Prostate Cancer Surgery, Ambulatory Care, Outpatient Surgery
In brief
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
Key facts
- Study ID
- NCT06822452
- Run by
- Elsan
- People needed
- 510
- Starts
- 2024-12-30
- Expected to finish
- 2030-04-30
- Last updated by the study team
- 2025-07-08
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Male, aged 18 and over
- Patient with prostate cancer for which the multidisciplinary meeting has proposed radical prostatectomy as a therapeutic option (with or without lymphadenectomy)
- Patient eligible for outpatient treatment :
- The patient undertakes to comply with all medical instructions given during surgical consultations and the anaesthetic consultation.
- The patient has access to personal transport allowing, if necessary, return to the facility or another approved facility (transport time and distance from the facility are not exclusion factors)
- The patient has access to telephone communication facilities.
- The patient undertakes not to drive a vehicle and to be accompanied on his return home and for the next 24 hours by a responsible person who will be familiar with the monitoring instructions.
- The patient plans to remain in hospital overnight if this is deemed necessary by the department's doctors (operator and anaesthetist). The patient accepts this mode of care and its constraints.
- Participant affiliated to or benefiting from a social security scheme
- The participant has been informed and has given his/her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research).
You may not qualify if…
- Patient already treated for prostatic carcinoma with brachytherapy, radiotherapy or focal therapy
- Patient participating in ongoing research or in a period of exclusion at the time of inclusion
- Refusal or inability to comply with the study protocol for any reason whatsoever
- Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Where it is running
- Polyclinique Les Fleurs — Ollioules, France (enrolling)
- Polyclinique Médipôle St-Roch — Cabestany, France (enrolling)
- Clinique Belledonne — Saint-Martin-d'Hères, France (enrolling)
- Clinique St Vincent — Besançon, France (enrolling)
- Hôpital Privé Océane — Vannes, France (enrolling)
- Pole Sante Sud-CMCM — Le Mans, France (enrolling)
- Clinique St Augustin — Bordeaux, France (enrolling)
- Hôpital Privé Nancy Lorraine — Nancy, France
- Polyclinique du Parc — Caen, France
- Clinique Rhône Durance — Avignon, France
- Polyclinique Santé Atlantique — Saint-Herblain, France
- Centre clinical — Soyaux, France
Full record on ClinicalTrials.gov
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