Robot-assisted outpatient surgery for localized prostate cancer
Pilot Feasibility Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer
This study is testing if men with localized prostate cancer can safely have robot-assisted surgery as outpatients without needing to stay in the hospital overnight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, CHU De Nice) |
| Trial ID | NCT04319146 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility of performing robot-assisted radical prostatectomy on an outpatient basis for men with localized prostate cancer. A total of 20 patients will be enrolled at a single center and followed for one month post-surgery. The study aims to determine the success rate based on the absence of hospital admission within 24 hours after the procedure and will assess complications and urinary incontinence during follow-up. The total duration of the study, including statistical analysis and publication, is 15 months.
Who should consider this trial
Good fit: Ideal candidates are men over 18 years old with localized prostate cancer who are eligible for outpatient radical prostatectomy.
Not a fit: Patients with a history of major abdominal surgery or sleep apnea syndrome may not benefit from this outpatient procedure.
Why it matters
Potential benefit: If successful, this approach could allow patients to undergo prostate cancer surgery with reduced hospital stays and quicker recovery times.
How similar studies have performed: While similar approaches have been explored, this specific outpatient robot-assisted technique is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nice, CHU De Nice
- CHU de NICE Pasteur 2 — Nice, CHU De Nice, France (Recruiting)
Study contacts
- Study coordinator: Youness AHALLAL, MD
- Email: ahallal.y@chu-nice.fr
- Phone: 0492036654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.