Comparing Two Different Approaches in Robotic-Assisted Renal Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparing the Modified Novel Trans-Retro Approach vs Conventional Retroperitoneal Approach in Robotic-Assisted Renal Surgery: An Open Label Randomized Controlled Trial

Conditions
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Renal Tumor

Intervention / Treatment
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* Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Renal vein tumor thrombus Pregnancy or suspected pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hybrid-Group<br>Laparoscopic and Robotic-assisted combined (partial) nephrectomy via the hybrid (trans-peritoneal and retroperitoneal) access route | Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)<br>* 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.<br>|
| Active Comparator: Retroperitoneal-Group<br>Robotic-assisted laparoscopic (partial) nephrectomy via the retroperitoneal access route | Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of the renal artery | Time from first skin incision to detection of the renal artery [Time in minutes] | During procedure/surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | The time from [Skin Incision] to [Skin Closure] in minutes as documented in OR-Management Information System | During procedure/surgery | 
| Robot docking time | The time from [Skin Incision] to [robot docking] in minutes as documented in OR-Spreadsheet. | During procedure/surgery | 
| Instrument insertion time | The time from [Skin Incision] to [insertion of the last instrument] in minutes as documented in OR-Spreadsheet | 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 | 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 | During procedure/surgery | 
| Surgical conversion to open surgery | Conversion from robotic to open surgery | During procedure/surgery | 
| Surgical conversion to radical nephrectomy | Conversion partial to radical nephrectomy | During procedure/surgery | 
| Intraoperative blood loss | Volume of blood loss during the surgical procedure in mL | 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) | 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) | During procedure/surgery | 
| Pain assessment | Assessment of pain level via the Visual Analogue Scale (VAS, 1-10, higher scores mean more pain) | 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) | 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] | 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 | Day 30 | 
| Length of stay Length of stay | Time from surgery to discharge in days [d] | During the hospital stay (up to day 7) | 
| Procedure related readmissions | Readmission that can be linked to the (partial) nephrectomy, binary [Yes/No] | Day 30 | 
| Procedure related reoperations | Re-operation that can be linked to the partial nephrectomy, binary [Yes/No] | Day 30 | 
| Comprehensive Complication Index | Any complication that occurred within 30 days post surgery, Scale [from 0 (no complication) to 100 (death)] | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic surgery, renal tumor