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

Not Applicable

Recruiting

• Conditions: Upper Tract Urothelial Cancer

• Registration Number: NCT06987552
• Lead Sponsor: National Taiwan University Hospital

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

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-24
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-06-30
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of conversion rate	During Surgery	The primary performance endpoint will be assessed as the ability to successfully completed the planned procedure with da Vinci SP System, with no conversion to alternative surgery including open surgery or laparoscopy.

Secondary Outcome Measures

Name	Time	Method
Complication	30 days post operation	Intraoperative and/or postoperative complication rate in 30 days by Clavien-Dindo Classification
Postoperative Parameters: Readmission	30 days post operation	Readmission rate by %
Postoperative Parameters: Reoperation	30 days post operation	Reoperation rate by %
Perioperative Mortality	30 days post operation	Mortality by %
Pain Score	30 days post operation	measured by Visual Analogue Scale (VAS) for pain assessment at baseline, post operation, and discharge day. VAS ranged from 0 to 10, representing no pain to extreme pain.
Perioperative Parameters: Operative Time	immediately after the surgery	First skin incision to closure of wound by minutes.
Perioperative Parameters: Console Time	immediately after the surgery	Surgeon on Console Time by minutes
Perioperative Parameters: Transfusion	immediately after the surgery	Blood transfusion amount by bags
Perioperative Parameters: Estimated Blood Loss	immediately after the surgery	Estimated blood loss by mL
Postoperative Parameters: Length of Stay	30 days post operation	Total length of stay = discharge date - admission date

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan