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

Centre Hospitalier Universitaire de Nice

Status

Active, not recruiting

Conditions

Prostate Cancer

Treatments

Procedure: robot-assisted radical prostatectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04319146

19-AOIP-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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