The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy-a Single Arm Pivotal Trial Initiated by Chang Gung Memorial Hospital, Taiwan
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Success rate (%)
研究概览
简要总结
The objective of this study is to evaluate the performance and safety of da Vinci Single Port (SP) system on the surgery for extraperitoneal approach radical prostatectomy
详细描述
Enrolled subjects would receive extraperitoneal approach radical prostatectomy using da Vinci SP system and be assessed at baseline (preoperatively), during hospitalization, and postoperatively (at 1 month +/-4 days, 3 month +/- 7 days, 6 months +/- 10 days, 12month +/-14 days). The preoperative assessment includes any diagnostic tests to confirm the subjects' cancer status and eligibility for the intervention under consideration such as transrectal or transperineal biopsy, image studies for staging including MRI/CT and bone scan, and cardiopulmonary tests to evaluate risks for anesthesia. The hospitalization assessment includes the collection of perioperative and postoperative details, conversions, and complications. The postoperative assessment includes regular follow up studies to evaluate cancer status and functional outcome (For sexual function, the International Index of Erectile Function (IIEF-5) would be recorded before and after the surgery. For continence, the number of pads per day and 24hr total weight of pads would be recorded. No pad used or one safe pad per day with net wet ≤ 50gm would be considered as continent. International Prostate Symptom Score (IPSS) wound be recorded before and after the surgery to access voiding function).
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 78 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy-proved prostate cancer
- •Stage clinical T1-T2N0M0
- •Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies)
- •BMI ≦ 35 kg/m
- •Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function)
- •Age between 18 and 78 years old
- •Suitable for minimally invasive surgery
- •Patients willing and able to provide informed consent
- •Patients willing and able to comply with study protocol requirements and follow-up
排除标准
- •Previous abdominal or pelvic major operation history
- •Previous radiation treatment to the pelvic area
- •Patients received transurethral resection of prostate in three months
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
- •Severe heart disease (NYHA functional class III-IV)
- •Severe lung disease (GOLD Group C-D)
- •Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
- •Hemodynamic or respiratory instability after anesthesia
- •Working space restriction (e.g. kyphosis or severe scoliosis)
- •Emergency surgery
- •Untreated active infection
- •vulnerable populations
结局指标
主要结局
Success rate (%)
时间窗: immediately after the surgery
Percentage of successful extraperitoneal approach radical prostatectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion.)
次要结局
- Perioperative parameters-blood transfusion unit(immediately after the surgery)
- Perioperative parameters-console time (minutes)(immediately after the surgery)
- Perioperative parameters-intra-operative complications (SATAVA system)(immediately after the surgery)
- Perioperative parameters-incision length (cm)(immediately after the surgery)
- Perioperative parameters-blood loss (ml)(immediately after the surgery)
- Perioperative parameters-blood transfusion type(immediately after the surgery)
- Postoperative parameters-length of hospital stay (days)(immediately after discharge (assessed up to 10 days))
- Postoperative parameters-analgesic type(Every day during admission after the surgery (up to 7 days))
- Functional outcomes-continence (leak amount in gram)(Post-operation 1/3/6/12 months)
- Perioperative parameters-oxidative stress(immediately after the surgery)
- Postoperative parameters-analgesic dose(Every day during admission after the surgery (up to 7 days))
- Functional outcomes-continence status(Post-operation 1/3/6/12 months)
- Functional outcomes-sexual function change (IIEF-5)(Baseline, Post-operation 1/3/6/12 months)
- Oncologic outcomes-biochemical recurrence(Post-operation 1/3/6/12 months)
- Postoperative parameters-pain scale (VAS score)(Every day during admission after the surgery (up to 7 days))
- Postoperative parameters-postoperative complications (CLAVIEN-DINDO system)(During admission after the surgery (up to 10 days))
- Functional outcomes-continence (pad amount)(Post-operation 1/3/6/12 months)
- Oncologic outcomes-margin status (positive or negative)(when the pathology report is available (up to day 10))
- Postoperative parameters-readmission and reoperation(If happens, on the day of re-admission or reoperations (up to 30 days))