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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Mar 23, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring the possibility of performing a type of surgery called robot-assisted radical prostatectomy on an outpatient basis for men with localized prostate cancer. This means that the surgery could be done without requiring an overnight hospital stay, allowing patients to go home the same day. The study aims to enroll 20 men who are interested in this option and will follow them for one month after the surgery to see how well it works and how safe it is.

To be eligible for the study, participants must be men over the age of 18 who have localized prostate cancer and are considering this surgery as their first treatment. They should be in good overall health, with a body mass index (BMI) under 35, and have someone to help them get home after the procedure. The trial is currently recruiting participants, and anyone interested would need to be able to understand the study details and sign a consent form. This study is an important step in finding out if outpatient robotic surgery can be a safe and effective treatment for prostate cancer.

Gender

MALE

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