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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: robot-assisted radical prostatectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youness AHALLAL, MD; Phone Number: 0492036654; Email: ahallal.y@chu-nice.fr
• Study Contact Backup: Name: Matthieu DURAND, Pr; Phone Number: 0492036654; Email: durand.m@chu-nice.fr

Study Locations

• France
  • CHU De Nice
    • Nice, CHU De Nice, France, 06000
      • Recruiting
      • CHU de NICE Pasteur 2
      • Contact: Youness AHALLAL, MD; Phone Number: 0492036654; Email: ahallal.y@chu-nice.fr
      • Contact: Matthieu DURAND, Pr; Phone Number: 0492036654; Email: durand.m@chu-nice.fr
      • Principal Investigator: Youness AHALLAL, MD
      • Sub-Investigator: Matthieu DURAND, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: robot-assisted radical prostatectomy; patient with a prostate cancer will be operated with a robot-assisted method. They will be supported on an outpatient basis	Procedure: robot-assisted radical prostatectomy; robot-assisted radical prostatectomy as first-line treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absence of conventional hospitalization after robot-assisted radical prostatectomy	24 hours following the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outpatient failure defined by a Chung score of less than 9 who cannot be discharged or admitted to a conventional hospitalization.		24 hours following the intervention
Mesure of the operation duration will be estimated in minutes and will be recorded with a stopwatch in the operating room	Start = time of the incision, End = skin closure	The day of surgery
The complication rate is determined by the number of patients who had one or more complications in the first month following the operation. Complications will be graded according to the Clavien Dindo classification.		within the month after surgery
The consultation rate in a doctor's office is set by the number of patients who consulted a general practitioner in the first month after the operation, declared by the patient during the control visite (at 1 month)		one month after surgery
•Any form of admission for urological reasons judged by the investigator in relation to robot-assisted radical prostatectomy within one month after the operation is considered as early unscheduled re-hospitalisation.		one month after surgery
Urinary incontinence is assessed by the ICIQ questionnaire at Month 1.	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)	one month after surgery
Patient satisfaction is assessed using the SSQ8 at Month 1.	SS8 is the Surgical Satisfaction questionnaire. There are 8 questions and the possible answers are Very satisfied, Sitisfied, Neutral, Unsatisfied, Very unsatisfied	one month after surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 19-AOIP-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan description is necessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No