Clinical trial NCT06987552: Single-Port RAS Using Da Vinci SP Surgical System for UTUC Patients
Official title: A Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Upper Tract Urothelial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Tract Urothelial Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
First posted: 2025-05-23
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Incidence of conversion rate
timeFrame: During Surgery
Secondary outcomes:
measure: Perioperative Parameters: Operative Time
timeFrame: immediately after the surgery
measure: Perioperative Parameters: Console Time
timeFrame: immediately after the surgery
measure: Perioperative Parameters: Transfusion
timeFrame: immediately after the surgery
measure: Perioperative Parameters: Estimated Blood Loss
timeFrame: immediately after the surgery
measure: Postoperative Parameters: Length of Stay
timeFrame: 30 days post operation
measure: Complication
timeFrame: 30 days post operation
measure: Postoperative Parameters: Readmission
timeFrame: 30 days post operation
measure: Postoperative Parameters: Reoperation
timeFrame: 30 days post operation
measure: Perioperative Mortality
timeFrame: 30 days post operation
measure: Pain Score
timeFrame: 30 days post operation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shih-Chieh Chueh
role: STUDY_DIRECTOR
References: