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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01745-42 | Other Identifier | ID-RCB |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient procedure | Experimental |
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| Inpatient procedure | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radical prostatectomy | Procedure | Robot-assisted |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| From the day of surgery to 8 days post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of surgery |
| Rate of cancellation of outpatient treatment by the patient or his private environment |
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Inclusion Criteria:
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 :
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlène PY, Eng | Contact | +33556003048 | charlene.py@elsan.care |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Rhône Durance | Not yet recruiting | Avignon | 84000 | France |
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Patients included in the study refusing outpatient care up to the day of surgery (before or after surgery) for whatever reason |
| 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 | From hospital discharge to 8 days post-operative. |
| Association of each early complication with treatment (outpatient or inpatient) | Early complication of robot-assisted prostatectomy | 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:
| 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. | 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. | 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. | 2 days and 45 days post-operative |
| Duration of surgery | Duration of surgery 'skin-to-skin' (incision until final stitch complete) | 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. | 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). | 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.) | 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. | 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). | 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:
| From hospital discharge to 6 months post-operative |
| Clinique St Vincent | Recruiting | Besançon | 25000 | France |
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| Clinique St Augustin | Recruiting | Bordeaux | 33074 | France |
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| Polyclinique Médipôle St-Roch | Recruiting | Cabestany | 66330 | France |
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| Polyclinique du Parc | Not yet recruiting | Caen | 14000 | France |
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| Pole Sante Sud-CMCM | Recruiting | Le Mans | 72100 | France |
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| Hôpital Privé Nancy Lorraine | Not yet recruiting | Nancy | 54100 | France |
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| Polyclinique Les Fleurs | Recruiting | Ollioules | 83190 | France |
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| Polyclinique Santé Atlantique | Not yet recruiting | Saint-Herblain | 44800 | France |
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| Clinique Belledonne | Recruiting | Saint-Martin-d'Hères | 38400 | France |
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| Centre clinical | Not yet recruiting | Soyaux | 16800 | France |
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| Hôpital Privé Océane | Recruiting | Vannes | 56000 | France |
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