1. detection of the renal artery (Time Frame - During procedure/surgery): Time from first skin incision to detection of the renal artery [Time in minutes]
Secondary outcome:
1. Operative time (Time Frame - During procedure/surgery): The time from [Skin Incision] to [Skin Closure] in minutes as documented in OR-Management Information System
2. Robot docking time (Time Frame - During procedure/surgery): The time from [Skin Incision] to [robot docking] in minutes as documented in OR-Spreadsheet.
3. Instrument insertion time (Time Frame - During procedure/surgery): The time from [Skin Incision] to [insertion of the last instrument] in minutes as documented in OR-Spreadsheet
4. Off-console time (Time Frame - During procedure/surgery): The time from [Skin Incision] to [start of first instrument movement by console surgeon] in minutes as documented in OR-Spreadsheet
5. Ischemia time (Time Frame - During procedure/surgery): The time from [Placement of clamp on artery] to [Release of clamp] in minutes indicated by the console surgeon documented by the anesthesiologist
6. Surgical conversion to open surgery (Time Frame - During procedure/surgery): Conversion from robotic to open surgery
7. Surgical conversion to radical nephrectomy (Time Frame - During procedure/surgery): Conversion partial to radical nephrectomy
8. Intraoperative blood loss (Time Frame - During procedure/surgery): Volume of blood loss during the surgical procedure in mL
9. Console surgeons perception of Trocar placement and working space (Time Frame - During procedure/surgery): Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)
10. Side assistants perception of Trocar placement and working space (Time Frame - During procedure/surgery): Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)
11. Pain assessment (Time Frame - During the hospital stay (up to day 7)): Assessment of pain level via the Visual Analogue Scale (VAS, 1-10, higher scores mean more pain)
12. Pain Management (Time Frame - During the hospital stay (up to day 7)): Documentation of pain management (according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment)
13. Kidney function via the estimated glomerular filtration rate (eGRF) (Time Frame - During the hospital stay (up to day 7)): Data will be gathered from routine examination, not a mandatory assessment (Lab value read-outs from in the clinical Information System) [ml/min/1,73 m2]
14. Post operative complications (Time Frame - Day 30): Any Clavien-Dindo I-V post-operative complication (standard classification for complication in surgery
15. Length of stay Length of stay (Time Frame - During the hospital stay (up to day 7)): Time from surgery to discharge in days [d]
16. Procedure related readmissions (Time Frame - Day 30): Readmission that can be linked to the (partial) nephrectomy, binary [Yes/No]
17. Procedure related reoperations (Time Frame - Day 30): Re-operation that can be linked to the partial nephrectomy, binary [Yes/No]
18. Comprehensive Complication Index (Time Frame - Day 30): Any complication that occurred within 30 days post surgery, Scale [from 0 (no complication) to 100 (death)]
Active Comparator: Hybrid-Group Laparoscopic and Robotic-assisted combined (partial) nephrectomy via the hybrid (trans-peritoneal and retroperitoneal) access route
Active Comparator: Retroperitoneal-Group Robotic-assisted laparoscopic (partial) nephrectomy via the retroperitoneal access route
Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN): laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) include bilateral tumors or tumors in a solitary kidney. Relative indications include familial renal cancer syndromes such as Von Hippel-Lindau, hereditary leiomyomatosis, or hereditary papillary renal cell carcinoma. Patients with chronic kidney disease are generally offered nephron sparing surgery for hope of future renal function preservation. This reasoning also applies to those patients with preexisting diseases that may threaten a solitary kidney such as uncontrolled diabetes and hypertension.
Quelle: ClinicalTrials.gov
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"Comparing Two Different Approaches in Robotic-Assisted Renal Surgery"
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