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Recruiting NCT06987552

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

No phase Interventional Upper Tract Urothelial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Da Vinci SP Surgical System.
Who it may be relevant to
Registry conditions: Upper Tract Urothelial Cancer. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device Da Vinci SP Surgical System
    Da Vinci SP Surgical System

Primary outcome measures

  • Incidence of conversion rate [Time frame: During Surgery]
Secondary outcome measures (10)
  • Perioperative Parameters: Operative Time [Time frame: immediately after the surgery]
  • Perioperative Parameters: Console Time [Time frame: immediately after the surgery]
  • Perioperative Parameters: Transfusion [Time frame: immediately after the surgery]
  • Perioperative Parameters: Estimated Blood Loss [Time frame: immediately after the surgery]
  • Postoperative Parameters: Length of Stay [Time frame: 30 days post operation]
  • Complication [Time frame: 30 days post operation]
  • Postoperative Parameters: Readmission [Time frame: 30 days post operation]
  • Postoperative Parameters: Reoperation [Time frame: 30 days post operation]
  • Perioperative Mortality [Time frame: 30 days post operation]
  • Pain Score [Time frame: 30 days post operation]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT06987552 · 202409016DIPD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗