Actively Recruiting
Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Upper Tract Urothelial Cancer
Led by National Taiwan University Hospital · Updated on 2025-05-23
25
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
I
Intuitive Surgical
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the patient-reported outcomes, safety, and surgical results of radical nephroureterectomy performed with a single-port robotic surgery system called the Da Vinci SP Surgical System. It focuses on patients diagnosed with upper tract urothelial cancer who are suitable candidates for this type of surgery. Participants will undergo radical nephroureterectomy and ipsilateral bladder cuff resection using the Da Vinci SP Surgical System. This single-port robotic surgery is being assessed for its feasibility and safety during the operation. The study will monitor perioperative parameters such as operative time, console time, blood loss, transfusion needs, and any complications occurring during or shortly after surgery. Throughout the study, patients will be closely followed for 30 days post-operation to assess length of hospital stay, readmission, reoperation, mortality, and pain levels. Researchers will record the incidence of conversion from robotic to open surgery during the procedure. Patient characteristics and outcomes will be collected to assess the overall surgical and recovery experience with this robotic technique.
CONDITIONS
Brief Title
Single-Port RAS Using Da Vinci SP Surgical System for UTUC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or more
- Histologically or cytologically diagnosed upper tract urothelial cancer
- Suitable for radical nephroureterectomy and ipsilateral bladder cuff resection with feasibility for robotic surgery
- ASA physical status classification 1 or 2 with adequate organ function
- Willing and able to comply with study protocol and follow-up
- Provided informed consent
You will not qualify if you...
- Presence of synchronous bladder cancer
- Distant metastasis of cancer
- Body mass index (BMI) less than 18.5 or 30 or more
- Unable to tolerate lateral decubitus or Trendelenburg position
- Severe adhesion from prior abdominopelvic surgery
- Previous radiation treatment to the pelvic area
- Active infectious disease
- Severe illness that greatly shortens life expectancy or increases surgery risk, including severe heart or lung disease
- Inability to follow trial procedures
- Systemic or pelvic disease increasing surgical risk
- Long-term use of anticoagulants
- Coagulopathy
- Emergency surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery day and immediate recovery period
Participants undergo single-port robot-assisted radical nephroureterectomy using the Da Vinci SP Surgical System followed by immediate recovery care.
1 surgery visit (in-person) and immediate post-operative care
Duration - 30 days post operation
Participants are monitored for complications, recovery progress, and patient-reported outcomes after surgery.
Approximately 1 to 2 follow-up visits within 30 days post operation
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
S
SHIH-CHIEH CHUEH, DIRECTOR
T
Taiwan National Taiwan University Hospital, DIRECTOR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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