The purpose of this study is to determine if the novel TR approach is superior to the standard RP approach. The anticipated study outcome is a time saving of at least 30% from first skin incision to detection of the renal artery compared to the conventional RP approach, and also a better workspace perception by the operating surgeon.
The trans abdominal approach (TA) for total and partial nephrectomy (PN) has been widely adopted due to the easy trocar placement and the good working space. The retroperitoneal approach (RP) has gained popularity because the renal artery is often found fast and the operation remains in an anatomically separated space, making it preferable, especially for patients who underwent abdominal surgery in the past. However, both approaches face difficulties. Trocar placement for RP can be challenging, and the working space often is limited, while TA is impaired in cases of dorsal tumors and dissection of the renal artery can be challenging due to the anatomic localization dorsally to the renal vein. Up until now, no direct systematically and prospective comparison of these two approaches was performed. The overall objective of this trial is to assess if the novel TR approach is superior to the conventional RP approach in performing robotic assisted (partial) nephrectomy. To date, no systematic, prospective, randomised study has been conducted on this topic and described in the literature.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Kantonsspital Baden
Baden, Canton of Aargau, Switzerland
detection of the renal artery
Time from first skin incision to detection of the renal artery \[Time in minutes\]
Time frame: During procedure/surgery
Operative time
The time from \[Skin Incision\] to \[Skin Closure\] in minutes as documented in OR-Management Information System
Time frame: During procedure/surgery
Robot docking time
The time from \[Skin Incision\] to \[robot docking\] in minutes as documented in OR-Spreadsheet.
Time frame: During procedure/surgery
Instrument insertion time
The time from \[Skin Incision\] to \[insertion of the last instrument\] in minutes as documented in OR-Spreadsheet
Time frame: During procedure/surgery
Off-console time
The time from \[Skin Incision\] to \[start of first instrument movement by console surgeon\] in minutes as documented in OR-Spreadsheet
Time frame: During procedure/surgery
Ischemia time
The time from \[Placement of clamp on artery\] to \[Release of clamp\] in minutes indicated by the console surgeon documented by the anesthesiologist
Time frame: During procedure/surgery
Surgical conversion to open surgery
Conversion from robotic to open surgery
Time frame: During procedure/surgery
Surgical conversion to radical nephrectomy
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Conversion partial to radical nephrectomy
Time frame: During procedure/surgery
Intraoperative blood loss
Volume of blood loss during the surgical procedure in mL
Time frame: During procedure/surgery
Console surgeons perception of Trocar placement and working space
Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)
Time frame: During procedure/surgery
Side assistants perception of Trocar placement and working space
Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)
Time frame: During procedure/surgery
Pain assessment
Assessment of pain level via the Visual Analogue Scale (VAS, 1-10, higher scores mean more pain)
Time frame: During the hospital stay (up to day 7)
Pain Management
Documentation of pain management (according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment)
Time frame: During the hospital stay (up to day 7)
Kidney function via the estimated glomerular filtration rate (eGRF)
Data will be gathered from routine examination, not a mandatory assessment (Lab value read-outs from in the clinical Information System) \[ml/min/1,73 m2\]
Time frame: During the hospital stay (up to day 7)
Post operative complications
Any Clavien-Dindo I-V post-operative complication (standard classification for complication in surgery
Time frame: Day 30
Length of stay Length of stay
Time from surgery to discharge in days \[d\]
Time frame: During the hospital stay (up to day 7)
Procedure related readmissions
Readmission that can be linked to the (partial) nephrectomy, binary \[Yes/No\]
Time frame: Day 30
Procedure related reoperations
Re-operation that can be linked to the partial nephrectomy, binary \[Yes/No\]
Time frame: Day 30
Comprehensive Complication Index
Any complication that occurred within 30 days post surgery, Scale \[from 0 (no complication) to 100 (death)\]
Time frame: Day 30