CHU de NICE Pasteur 2
Nice, CHU de Nice, 06000, France
NCT Number: NCT04319146
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Male
Interventional
Not applicable
Nice, CHU de Nice, 06000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
robot-assisted radical prostatectomy as first-line treatment
Time frame: 24 hours following the intervention
Time frame: 24 hours following the intervention
Time frame: The day of surgery
Start = time of the incision, End = skin closure
Time frame: within the month after surgery
Time frame: one month after surgery
Time frame: one month after surgery
Time frame: one month after surgery
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)
Time frame: one month after surgery
SS8 is the Surgical Satisfaction questionnaire. There are 8 questions and the possible answers are Very satisfied, Sitisfied, Neutral, Unsatisfied, Very unsatisfied
Centre Hospitalier Universitaire de Nice
Other
Pilot Feasibility Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer
Acronym: AMBUPRO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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