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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
Clinique Rhône Durance
NOT_YET_RECRUITING
Avignon
Clinique St Vincent
RECRUITING
Besançon
Clinique St Augustin
RECRUITING
Bordeaux
Polyclinique Médipôle St-Roch
RECRUITING
Cabestany
Polyclinique du Parc
NOT_YET_RECRUITING
Caen
Pole Sante Sud-CMCM
RECRUITING
Le Mans
Hôpital Privé Nancy Lorraine
NOT_YET_RECRUITING
Nancy
Polyclinique Les Fleurs
RECRUITING
Ollioules
Polyclinique Santé Atlantique
NOT_YET_RECRUITING
Saint-herblain
Clinique Belledonne
RECRUITING
Saint-martin-d'hères
Centre clinical
NOT_YET_RECRUITING
Soyaux
Hôpital Privé Océane
RECRUITING
Vannes
Contact Information
Primary
Charlène PY, Eng
charlene.py@elsan.care
+33556003048
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 510
Treatments
Experimental: Outpatient procedure
Active_comparator: Inpatient procedure
Related Therapeutic Areas
Sponsors
Leads: Elsan

This content was sourced from clinicaltrials.gov