Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
NCT ID: NCT06822452
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
510 participants
INTERVENTIONAL
2024-12-30
2030-04-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Outpatient procedure
radical prostatectomy
Robot-assisted
Inpatient procedure
radical prostatectomy
Robot-assisted
Interventions
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radical prostatectomy
Robot-assisted
Eligibility Criteria
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Inclusion Criteria
* 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 :
1. The patient undertakes to comply with all medical instructions given during surgical consultations and the anaesthetic consultation.
2. 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)
3. The patient has access to telephone communication facilities.
4. 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.
5. 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).
Exclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
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Elsan
OTHER
Responsible Party
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Locations
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Clinique Rhône Durance
Avignon, , France
Clinique St Vincent
Besançon, , France
Clinique St Augustin
Bordeaux, , France
Polyclinique Médipôle St-Roch
Cabestany, , France
Polyclinique du Parc
Caen, , France
Pole Sante Sud-CMCM
Le Mans, , France
Hôpital Privé Nancy Lorraine
Nancy, , France
Polyclinique Les Fleurs
Ollioules, , France
Polyclinique Santé Atlantique
Saint-Herblain, , France
Clinique Belledonne
Saint-Martin-d'Hères, , France
Centre clinical
Soyaux, , France
Hôpital Privé Océane
Vannes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-A01745-42
Identifier Type: OTHER
Identifier Source: secondary_id
PROSTAMBU
Identifier Type: -
Identifier Source: org_study_id
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