Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer (AMBUPRO)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
robot-assisted radical prostatectomy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
robot-assisted radical prostatectomy
Arm Description
patient with a prostate cancer will be operated with a robot-assisted method. They will be supported on an outpatient basis
Outcomes
Primary Outcome Measures
Absence of conventional hospitalization after robot-assisted radical prostatectomy
Secondary Outcome Measures
Outpatient failure defined by a Chung score of less than 9 who cannot be discharged or admitted to a conventional hospitalization.
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 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.
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)
•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.
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)
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
Full Information
NCT ID
NCT04319146
First Posted
March 17, 2020
Last Updated
August 10, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04319146
Brief Title
Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer
Acronym
AMBUPRO
Official Title
Pilot Feasibility Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label, monocentric study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
robot-assisted radical prostatectomy
Arm Type
Other
Arm Description
patient with a prostate cancer will be operated with a robot-assisted method. They will be supported on an outpatient basis
Intervention Type
Procedure
Intervention Name(s)
robot-assisted radical prostatectomy
Intervention Description
robot-assisted radical prostatectomy as first-line treatment
Primary Outcome Measure Information:
Title
Absence of conventional hospitalization after robot-assisted radical prostatectomy
Time Frame
24 hours following the intervention
Secondary Outcome Measure Information:
Title
Outpatient failure defined by a Chung score of less than 9 who cannot be discharged or admitted to a conventional hospitalization.
Time Frame
24 hours following the intervention
Title
Mesure of the operation duration will be estimated in minutes and will be recorded with a stopwatch in the operating room
Description
Start = time of the incision, End = skin closure
Time Frame
The day of surgery
Title
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.
Time Frame
within the month after surgery
Title
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)
Time Frame
one month after surgery
Title
•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.
Time Frame
one month after surgery
Title
Urinary incontinence is assessed by the ICIQ questionnaire at Month 1.
Description
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
Title
Patient satisfaction is assessed using the SSQ8 at Month 1.
Description
SS8 is the Surgical Satisfaction questionnaire. There are 8 questions and the possible answers are Very satisfied, Sitisfied, Neutral, Unsatisfied, Very unsatisfied
Time Frame
one month after surgery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan description is necessary
Learn more about this trial
Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer
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