Single-Port RAS Using Da Vinci SP Surgical System for UTUC Patients

National Taiwan University

Status

Enrolling

Conditions

Upper Tract Urothelial Cancer

Treatments

Device: Da Vinci SP Surgical System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06987552

202409016DIPD

Details and patient eligibility

About

To evaluate patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery

Full description

To evaluate safety, surgical outcomes, patient characteristics, and patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery

Enrollment

25 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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