Comparing Two Different Approaches in Robotic-Assisted Renal Surgery
- Conditions
- Renal Tumor
- Interventions
- Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)
- Registration Number
- NCT05377632
- Lead Sponsor
- Lukas J Hefermehl
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Age 18 years or older
- Patient with a renal tumor or non-functionally kidney that is a candidate for robotic assisted surgery (RAS) nephrectomy or partial nephrectomy (PN)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Renal vein tumor thrombus
- Pregnancy or suspected pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hybrid-Group Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) Laparoscopic and Robotic-assisted combined (partial) nephrectomy via the hybrid (trans-peritoneal and retroperitoneal) access route Retroperitoneal-Group Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) Robotic-assisted laparoscopic (partial) nephrectomy via the retroperitoneal access route
- Primary Outcome Measures
Name Time Method detection of the renal artery During procedure/surgery Time from first skin incision to detection of the renal artery \[Time in minutes\]
- Secondary Outcome Measures
Name Time Method Intraoperative blood loss During procedure/surgery Volume of blood loss during the surgical procedure in mL
Operative time During procedure/surgery The time from \[Skin Incision\] to \[Skin Closure\] in minutes as documented in OR-Management Information System
Robot docking time During procedure/surgery The time from \[Skin Incision\] to \[robot docking\] in minutes as documented in OR-Spreadsheet.
Instrument insertion time During procedure/surgery The time from \[Skin Incision\] to \[insertion of the last instrument\] in minutes as documented in OR-Spreadsheet
Ischemia time 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
Surgical conversion to open surgery During procedure/surgery Conversion from robotic to open surgery
Surgical conversion to radical nephrectomy During procedure/surgery Conversion partial to radical nephrectomy
Off-console time During procedure/surgery The time from \[Skin Incision\] to \[start of first instrument movement by console surgeon\] in minutes as documented in OR-Spreadsheet
Console surgeons perception of Trocar placement and working space During procedure/surgery Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)
Side assistants perception of Trocar placement and working space During procedure/surgery Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)
Procedure related reoperations Day 30 Re-operation that can be linked to the partial nephrectomy, binary \[Yes/No\]
Comprehensive Complication Index Day 30 Any complication that occurred within 30 days post surgery, Scale \[from 0 (no complication) to 100 (death)\]
Pain assessment 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)
Procedure related readmissions Day 30 Readmission that can be linked to the (partial) nephrectomy, binary \[Yes/No\]
Pain Management 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)
Kidney function via the estimated glomerular filtration rate (eGRF) 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) \[ml/min/1,73 m2\]
Post operative complications Day 30 Any Clavien-Dindo I-V post-operative complication (standard classification for complication in surgery
Length of stay Length of stay During the hospital stay (up to day 7) Time from surgery to discharge in days \[d\]
Trial Locations
- Locations (1)
Kantonsspital Baden
🇨ðŸ‡Baden, Aargau, Switzerland