NCT04319146

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	robot-assisted radical prostatectomy	robot-assisted radical prostatectomy as first-line treatment

Timeline

• Start date: 2022-01-25
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-03-24
• Last updated: 2025-12-04

Locations

1 site across 1 country: France