Status:
RECRUITING
Single-Port RAS Using Da Vinci SP Surgical System for UTUC Patients
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Intuitive Surgical
Conditions:
Upper Tract Urothelial Cancer
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
To evaluate patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
Detailed Description
To evaluate safety, surgical outcomes, patient characteristics, and patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
Eligibility Criteria
Inclusion
- Age 20 years or more
- Histologically or cytologically diagnosed upper tract urothelial cancer
- Fitting indications of radical nephroureterectomy and ipsilateral bladder cuff resection, and deemed feasible for robotic surgery
- ASA physical status classification 1-2 and adequate organ function
- Patients willing and able to comply with study protocol requirements and follow-up
- With informed consent
Exclusion
- Synchronous bladder cancer
- Distant metastasis of cancer
- BMI ≥30 or BMI \<18.5
- Unable to tolerate lateral decubitus or Trendelenburg position (relative contra-indication)
- Severe adhesion due to prior abdominopelvic surgery (relative contra-indication)
- Previous radiation treatment to the pelvic area
- Active infectious disease
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions, such as: severe heart disease (NYHA functional class III-IV) or severe lung disease (GOLD Group C-D)
- Cannot follow trial-required procedures
- Concomitant systemic or pelvic disease that increases the risk of surgery
- Long-term use of anti-coagulant(s)
- Patients with coagulopathy
- Emergency surgery
Key Trial Info
Start Date :
December 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06987552
Start Date
December 24 2024
End Date
January 1 2026
Last Update
May 23 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan