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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
510
Robot-assisted
Clinique Rhône Durance
Avignon, France
NOT_YET_RECRUITINGClinique St Vincent
Besançon, France
RECRUITINGClinique St Augustin
Bordeaux, France
RECRUITINGPolyclinique Médipôle St-Roch
Cabestany, France
RECRUITINGPolyclinique du Parc
Caen, France
NOT_YET_RECRUITINGPole Sante Sud-CMCM
Le Mans, France
RECRUITINGHôpital Privé Nancy Lorraine
Nancy, France
NOT_YET_RECRUITINGPolyclinique Les Fleurs
Ollioules, France
RECRUITINGPolyclinique Santé Atlantique
Saint-Herblain, France
NOT_YET_RECRUITINGClinique Belledonne
Saint-Martin-d'Hères, France
RECRUITING...and 2 more locations
Early complication of robot-assisted prostatectomy
The occurrence (yes/no) of at least one early complication of robot-assisted prostatectomy. The early clinical complications expected are : * Bleeding from trocar incision scars or surgical excision scars * Urinary leakage around the catheter * Retention due to bladder catheter clotting * Loss of bladder catheter * Signs of internal haemorrhage (within 24 hours) * Signs of biological deglobulation * Intestinal obstruction syndrome * Signs of urinary fistula * Infectious signs : fever \> 38°, chills * Thromboembolicaccidents * Nosocomial infections * Falls
Time frame: From the day of surgery to 8 days post-operative
Conversion rate from outpatient to full hospitalisation (Outpatient failure rate)
Patients treated on an outpatient basis for whom full hospitalisation is indicated on the day of surgery, as decided by the medical team.
Time frame: Day of surgery
Rate of cancellation of outpatient treatment by the patient or his private environment
Patients included in the study refusing outpatient care up to the day of surgery (before or after surgery) for whatever reason
Time frame: From enrollment to the day of surgery
Rate of patients readmitted to hospital, either as emergencies or in the department
Patients readmitted to hospital (yes/no), emergency or inpatient department
Time frame: From hospital discharge to 8 days post-operative.
Association of each early complication with treatment (outpatient or inpatient)
Early complication of robot-assisted prostatectomy
Time frame: From hospitalisation discharge to 8 days post-operative
Rate of patients having had at least one complication secondary to surgery
Patients who had at least one complication secondary to surgery. The expected complications secondary to surgery are: * Admission to emergency care * Re-hospitalization * Occlusions * Healing problems * Perineal hematoma * Urinary infections * Lymphoceles * Thromboembolic accidents * Nosocomial infections
Time frame: From 8 days to 45 days post-operative
Rate of patients with at least one complication secondary to surgery
Patients who had at least one complication secondary to surgery.
Time frame: From 45 days to 6 months post-operative
Patient's pre-operative stress/anxiety levels
The participant's stress/anxiety level is assessed at 3 days before surgery using the APAIS (Amsterdam Preoperative Anxiety and Information Scale) questionnaire validated in French (Moerman and al, 1996; Maurice-Szamburski and al, 2013), then with a Numerical Scale of stress/anxiety during preparation for the operating theatre in the care unit and at 2 days post-operative.
Time frame: 3 days before surgery, day of surgery and 2 days post-operative
Patient satisfaction level
Patient satisfaction is assessed using the overall satisfaction question in the e-SATIS questionnaire ("Overall, how would you rate the quality of your treatment/care in the department by the doctors/surgeons/nurses? Bad/Weak/Average/Good/Excellent) The patient's opinion (yes/no) is evaluated on whether, if the procedure were repeated, the patient would accept it (yes/no) and whether it reassured him/her to go home in the evening /stay in hospital at night after the procedure.
Time frame: 2 days and 45 days post-operative
Duration of surgery
Duration of surgery 'skin-to-skin' (incision until final stitch complete)
Time frame: Day of surgery
Blood loss
The level of blood loss is assessed by the quantity of blood recovered in the aspiration jar and the quantity from the drains minus the quantity perfused intraoperatively in ml.
Time frame: Day of surgery
Rate of patients who recovered continence and rate of patients who recovered urinary function after surgery
Urinary continence is assessed by the response to question 5 of the EPIC-50 (Expanded Prostate Cancer Index Composite) when 0 to 1 pads are used during the day by the patient. Recovery of urinary function was assessed by the difference between the incontinence subscore of the EPIC-50 questionnaire at D45 and the value of the pre-operative score. The incontinence subscore include questions 1, 3, 4, 5 and 6a of the urinary function EPIC-50 questionnaire. The EPIC-50 is a validated questionnaire (Wei and al, 2000) and translated into French (Anota and al, 2016).
Time frame: Baseline and 45 days post-operative
Evolution of urinary continence between 45 days and 6 months post-operatively and evolution of urinary function pre-operatively, at 45 days, at 6 months.
The evolution of continence and urinary function is established on the basis of the parameters defined previously (see Secondary Outcome Measure 12.)
Time frame: Baseline and 45 days, 6 months after surgery
Recovery of erectile function
Erectile recovery is assessed using the IIEF-5 (International Index of Erectile Function) questionnaire (Rosen R and al, 1997; Dargis and al, 2013) ; erectile dysfunction is defined by an IIEF-5 score \<10.
Time frame: Baseline and 6 months post-operative
Oncological recurrence and retreatment
Recurrence is defined by a PSA (Prostate Specific Antigen) level \>0.1ng/ml, the patient's re-treatment (yes/no), the type of re-treatment (hormone therapy / chemotherapy / radiotherapy).
Time frame: From 45 days to 5 years after surgery
Economic and social cost of patient care
The cost-utility ratio calculated on the basis of : \- The costs of the homogeneous group of patients (GHM) for hospitalisation and the costs of the national care reference system (ENCC) for post-operative management, based on the patient's diary completed up to 6 months after the operation. The following direct medical costs will be estimated from a societal perspective with a time horizon of 6 months: * Medical transport, medical and non-medical consultations in town, complementary examinations and drugs: collected in the CRF of the study from the patient logbook and valued using current tariffs. * The QALY, a unit for measuring life expectancy weighted by health-related quality of life, calculated on the basis of the utility derived from the EQ-5D-5L quality of life questionnaire completed by the patient at D0, D45 and 6 months after surgery.
Time frame: From hospital discharge to 6 months post-operative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.