RecruitingNot ApplicableNCT06987552
Single-Port RAS Using Da Vinci SP Surgical System for UTUC Patients
A Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Upper Tract Urothelial Cancer
Sponsor
National Taiwan University Hospital
Enrollment
25 participants
Start Date
Dec 24, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
Eligibility
Min Age: 20 Years
Inclusion Criteria6
- 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 Criteria13
- 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
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Interventions
DEVICEDa Vinci SP Surgical System
Da Vinci SP Surgical System
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06987552
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