Status:
UNKNOWN
The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Intuitive Surgical
Conditions:
Prostate Cancer
Eligibility:
MALE
18-78 years
Phase:
NA
Brief Summary
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
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05403190
Start Date
August 1 2022
End Date
November 30 2023
Last Update
February 22 2023
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333