Prostate Cancer Clinical Trial
— AMBUPROOfficial title:
Pilot Feasibility Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de NICE Pasteur 2 | Nice | CHU De Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absence of conventional hospitalization after robot-assisted radical prostatectomy | 24 hours following the intervention | ||
Secondary | 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 | ||
Secondary | 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 | |
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | •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 | ||
Secondary | 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 | |
Secondary | 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 |
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