Pilot Feasibility Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Absence of conventional hospitalization after robot-assisted radical prostatectomy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: robot-assisted radical prostatectomy (Procedure)
结局指标
主要结局
Absence of conventional hospitalization after robot-assisted radical prostatectomy
时间窗: 24 hours following the intervention
次要结局
- 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)
- •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.(one month after surgery)
- 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)
- 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)
- Mesure of the operation duration will be estimated in minutes and will be recorded with a stopwatch in the operating room(The day of surgery)
- Patient satisfaction is assessed using the SSQ8 at Month 1.(one month after surgery)