n-blinded Multicenter Study to Assess the Safety and Efficacy of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Renal Cell Carcinoma Patients
Not Applicable
- Conditions
- cT1 Renal Canser
- Registration Number
- JPRN-UMIN000013964
- Lead Sponsor
- Kobe University Graduate School of Medicine
- Brief Summary
The achievement rate of the primary endpoint was 91.3% (95%CI:84.1-95.9%). It was significantly higher than the preset threshold (23.3%).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 118
Inclusion Criteria
Not provided
Exclusion Criteria
1)multiple cancer 2)history of kidney transplantation. 3)therapies for renal cell cancer in the past 6 months. 4)unable to withdrawal of anticoagulation 5)anemia or hemorrhagic tendency requiring transfusion 6)obesity(Body Mass Index:BMI>=35) 7)dialysis patient. 8)pregnant, suspected of being pregnant, or lactating woman. 9)difficult to participate the study due to psychiatric disorder or psychological symptom. 10)inappropriate by the investigator or sub-investigator at the hospital (site) for any other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Preservation of renal function and radical resection of renal cell carcinoma (negative surgical margin and ischemic time <25min.)
- Secondary Outcome Measures
Name Time Method -Surgical time -Console time -Intraoperative blood loss -Renal function (eGFR) -Complete rate of the robotic-assisted laparoscopic partial nephrectomy -Conversion to open surgery or laparoscopic surgery -Postoperative recovery process (the date of first intraoral intake, postoperative hospital stay) -Overall survival period -Recurrence-free survival time -Perioperative (during and early postoperative) adverse events (urine leakage, hemorrhage, etc.) -Postoperative adverse events -Late postoperative adverse events (cardiac, cerebrovascular diseases) -Mechanical defects