Upper Tract Urothelial Cancer
Conditions
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
Interventions
Da Vinci SP Surgical System
Sponsors
Intuitive Surgical
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| Complication | 30 days post operation | Intraoperative and/or postoperative complication rate in 30 days by Clavien-Dindo Classification |
Countries
Taiwan
Contacts
Primary ContactSHIH-CHIEH CHUEH, DIRECTOR
Backup ContactTaiwan National Taiwan University Hospital, DIRECTOR
Outcome results
None listed