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