Outpatient versus inpatient robot-assisted prostate removal surgery
Compares early complications of robot-assisted prostate removal done as day surgery or with a stay.
Key facts
- Who runs it
- Elsan
- Where
- Avignon, Besançon, Bordeaux, Cabestany, Caen, Le Mans, Nancy, Ollioules, Saint-Herblain, Saint-Martin-d'Hères, Soyaux, and Vannes, FranceSee the 12 sites
- Trial code
- Registry title
- Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
- Status
- Recruiting
- People taking part
- 510 people, planned
- Started
- 30 Dec 2024
- Expected to end
- 30 Apr 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- radical prostatectomy
- Record updated
- 8 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer who are planned to have robot-assisted radical prostatectomy and who can be treated as outpatients.
- Age
- 18 years and over
- Sex
- Men only
- Disease stage
- Prostate cancer for which the multidisciplinary meeting has proposed radical prostatectomy, with or without lymph node removal
- Earlier treatment
- Cannot have had brachytherapy, radiotherapy or focal therapy for prostate cancer before
Main reasons for not taking part
- Already treated for prostate cancer with brachytherapy, radiotherapy or focal therapy
- Taking part in other ongoing research or in an exclusion period
- Refusal or inability to follow the study protocol
- Adult under guardianship, curatorship or other legal protection, or deprived of liberty by court or administrative decision
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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 in France
- Clinique Rhône DuranceAvignon, FranceContact: Christophe CLEMENT, MDNot yet recruiting
- Clinique St VincentBesançon, FranceContact: Clément DARCQ, MDTaking people
- Clinique St AugustinBordeaux, FranceContact: Jean-Luc HOEPFFNER, MDTaking people
- Polyclinique Médipôle St-RochCabestany, FranceContact: Nicolas LETANG, MDTaking people
- Polyclinique du ParcCaen, FranceContact: Rayan ATME, MDNot yet recruiting
- Pole Sante Sud-CMCMLe Mans, FranceContact: Olivier BELAS, MDTaking people
- Hôpital Privé Nancy LorraineNancy, FranceContact: Nicolas HUBERT, MDNot yet recruiting
- Polyclinique Les FleursOllioules, FranceContact: Olivier ALENDA, MDTaking people
- Polyclinique Santé AtlantiqueSaint-Herblain, FranceContact: Quentin Come LE CLERC, MDNot yet recruiting
- Clinique BelledonneSaint-Martin-d'Hères, FranceContact: Jean-Alexandre LONG, MDTaking people
- Centre ClinicalSoyaux, FranceContact: Olivier LAPOUGE, MDNot yet recruiting
- Hôpital privé OcéaneVannes, FranceContact: Hervé MONSAINT, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 2 groups in the trial
- Outpatient procedureTreatment being tested
Treatment: radical prostatectomy
- Inpatient procedureExisting treatment, for comparison
Treatment: radical prostatectomy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
- Plain-language title
- Outpatient versus inpatient robot-assisted prostate removal surgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 8 July 2025