Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The promoter propose a pilot study evaluating the feasability of robot-assisted radical prostatectomy on outpatient in patients with localized prostate cancer. This study will enrole a total of 20 patients over one center, followed for 1 month. The total study duration will be 15 months, including statistical analysis and publication.

Detailed Description
-----------------
The promoter propose to carry out a monocentric biomedical cohort study, interventional, falling within the scope of the law of the public health code of 9 August 2004, for a total duration of 15 months including statistical analysis and publication. This analysis will involve a total of 20 patients, followed for 1 month during which the study criteria will be evaluated. The patients concerned are men over 18 years of age (with a favourable onco-geriatric opinion if >70 years) with localised prostate cancer who are candidates for treatment by radical prostatectomy as first-line treatment. Patients must have a BMI of less than 35 kg/m², an ASA score of less than 3 and signed consent. Patients with a history of major abdominal surgery or sleep apnea syndrome will not be eligible. The success rate of robot-assisted radical prostatectomy on an outpatient basis is defined by the absence of admission to a conventional inpatient unit within the first 24 hours after the procedure; the admission criterion being a Chung score of >9 (street-readiness score) or a complication during the procedure that does not allow the patient to be discharged. Concerning post-operative follow-up, on D+1, readmissions and complications will be sought by the RAAC coordination nurse. The patient will be seen again at 1 month, during which time possible consultations and/or readmissions for events related to the operation will be sought. Urinary incontinence will be investigated by completing the ICIQ continence questionnaire and early oncological findings (PAS and histology of the surgical specimen) will be evaluated. Patient satisfaction with ambulatory surgery will be assessed using the SSQ8 questionnaire collected at this visit. Investigators are selected on the basis of their surgical experience for this technique and must have performed a minimum of 20 personal procedures.

Official Title
-----------------
Pilot Feasibility Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: robot-assisted radical prostatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men Older than 18 years old, if> 70 years old, then patient having had a favorable onco-geriatric consultation (Balducci 2 and life expectancy> 10 years) Patient with localized prostate cancer applying for radical prostatectomy treatment Patient accepting outpatient surgery Radical prostatectomy performed as first-line treatment BMI <35 ASA score <3 Accompanying person available (taxi authorized) to ensure return home Have quick access to a telephone line Patient who signed their informed consent Patient covered by social security or other health insurance Exclusion Criteria: History of major abdominal surgery History of pelvic radiotherapy History of major urogenital malformation Sleep apnea syndrome Taking the following drugs within 48 hours (Plavix®, anti-vitamin K / curative LMWH) Contraindication to ambulatory medical care Inability to understand and sign the informed consent and to complete the self-questionnaires Vulnerable people

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label, monocentric study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: robot-assisted radical prostatectomy<br>patient with a prostate cancer will be operated with a robot-assisted method. They will be supported on an outpatient basis | Procedure: robot-assisted radical prostatectomy<br>* robot-assisted radical prostatectomy as first-line treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of conventional hospitalization after robot-assisted radical prostatectomy |  | 24 hours following the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outpatient failure defined by a Chung score of less than 9 who cannot be discharged or admitted to a conventional hospitalization. |  | 24 hours following the intervention | 
| Mesure of the operation duration will be estimated in minutes and will be recorded with a stopwatch in the operating room | Start = time of the incision, End = skin closure | The day of surgery | 
| The complication rate is determined by the number of patients who had one or more complications in the first month following the operation. Complications will be graded according to the Clavien Dindo classification. |  | within the month after surgery | 
| The consultation rate in a doctor's office is set by the number of patients who consulted a general practitioner in the first month after the operation, declared by the patient during the control visite (at 1 month) |  | one month after surgery | 
| •Any form of admission for urological reasons judged by the investigator in relation to robot-assisted radical prostatectomy within one month after the operation is considered as early unscheduled re-hospitalisation. |  | one month after surgery | 
| Urinary incontinence is assessed by the ICIQ questionnaire at Month 1. | ICIQ is the incontinence international questionnaire used to evaluate the frequence, quantity and the interference of urine leakage. There are 3 questions and the sum of their answers gives the ICIQ score (between 0 and 21) | one month after surgery | 
| Patient satisfaction is assessed using the SSQ8 at Month 1. | SS8 is the Surgical Satisfaction questionnaire. There are 8 questions and the possible answers are Very satisfied, Sitisfied, Neutral, Unsatisfied, Very unsatisfied | one month after surgery |