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Recruiting

NCT Number: NCT06987552

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

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

Recruiting

Interested in participating?

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

SHIH-CHIEH CHUEH

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Da Vinci SP Surgical System

Device

Da Vinci SP Surgical System

Primary outcomes

  1. Incidence of conversion rate

    Time frame: 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 outcomes

  1. Perioperative Parameters: Operative Time

    Time frame: immediately after the surgery

    First skin incision to closure of wound by minutes.

  2. Perioperative Parameters: Console Time

    Time frame: immediately after the surgery

    Surgeon on Console Time by minutes

  3. Perioperative Parameters: Transfusion

    Time frame: immediately after the surgery

    Blood transfusion amount by bags

  4. Perioperative Parameters: Estimated Blood Loss

    Time frame: immediately after the surgery

    Estimated blood loss by mL

  5. Postoperative Parameters: Length of Stay

    Time frame: 30 days post operation

    Total length of stay = discharge date - admission date

  6. Complication

    Time frame: 30 days post operation

    Intraoperative and/or postoperative complication rate in 30 days by Clavien-Dindo Classification

  7. Postoperative Parameters: Readmission

    Time frame: 30 days post operation

    Readmission rate by %

  8. Postoperative Parameters: Reoperation

    Time frame: 30 days post operation

    Reoperation rate by %

  9. Perioperative Mortality

    Time frame: 30 days post operation

    Mortality by %

  10. Pain Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

SHIH-CHIEH CHUEH, DIRECTOR

CONTACT

[email protected]

02 23123456 ext. 262134

Taiwan National Taiwan University Hospital, DIRECTOR

CONTACT

[email protected]

02 23123456 ext. 262134

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Intuitive Surgical

Registry information

Official study title

A Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Upper Tract Urothelial Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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