Single-Port RAS Using Da Vinci SP Surgical System for UTUC Patients
ConditionUpper Tract Urothelial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
To evaluate patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Synchronous bladder cancer
Distant metastasis of cancer
BMI ≥30 or BMI <18.5
Unable to tolerate lateral decubitus or Trendelenburg position (relative contra-indication)
Trial design
Design model
Single group
Treatments tested in this trial
Da Vinci SP Surgical System
DeviceDa Vinci SP Surgical System
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Operation of focus procedure with da Vinci SP Surgery SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of conversion rate
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.
Time frame
During SurgerySecondary outcomes
1
Perioperative Parameters: Operative Time
First skin incision to closure of wound by minutes.
Time frame
immediately after the surgery2
Perioperative Parameters: Console Time
Surgeon on Console Time by minutes
Time frame
immediately after the surgery3
Perioperative Parameters: Transfusion
Blood transfusion amount by bags
Time frame
immediately after the surgery4
Perioperative Parameters: Estimated Blood Loss
Estimated blood loss by mL
Time frame
immediately after the surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
Intuitive Surgical
Collaborator
Source ClinicalTrials.gov