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NCT06822452Recruiting

Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.

Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
510 (estimated)
First submitted
31 Jan 2025
Start date
30 Dec 2024
Primary completion date
7 Jan 2027
Lead sponsor
Elsan
NCT number
NCT06822452

What you commit to

  • Study type: Interventional
  • Planned participants: 510
  • From 30 Dec 2024 to the primary completion date, 7 Jan 2027
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient already treated for prostatic carcinoma with brachytherapy, radiotherapy or focal therapy

Other

  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Clinique Rhône Durance
Coordinator of this site? Confirm its status
AvignonFranceNot yet recruiting
Clinique St Vincent
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BesançonFranceRecruiting
Clinique St Augustin
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Polyclinique Médipôle St-Roch
Coordinator of this site? Confirm its status
CabestanyFranceRecruiting
Polyclinique du Parc
Coordinator of this site? Confirm its status
CaenFranceNot yet recruiting
Pole Sante Sud-CMCM
Coordinator of this site? Confirm its status
Le MansFranceRecruiting
Hôpital Privé Nancy Lorraine
Coordinator of this site? Confirm its status
NancyFranceNot yet recruiting
Polyclinique Les Fleurs
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OllioulesFranceRecruiting
Polyclinique Santé Atlantique
Coordinator of this site? Confirm its status
Saint-HerblainFranceNot yet recruiting
Clinique Belledonne
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Saint-Martin-d'HèresFranceRecruiting
Centre Clinical
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SoyauxFranceNot yet recruiting
Hôpital privé Océane
Coordinator of this site? Confirm its status
VannesFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.