Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy

Study Overview
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Brief Summary
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Both laparoscopic partial nephrectomy (LPN) and robotic partial nephrectomy (RPN) can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of retroperitoneum cavity. However, with advanced surgical skills and thoughtful patient selection, RP approach may be associated with shorter operative time (OT), less estimated blood loss (EBL), shorter length of hospital stay (LOS) compared with TP approach. Therefore, the investigators performed randomized control trial to compare the outcomes of the two approaches (TP-LPN or RPN vs RP-LPN or RPN).

Detailed Description
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Partial nephrectomy is the standard treatment for small renal masses. The evolution of minimally invasive partial nephrectomy led to widespread utilization of laparoscopic (LPN) and robotic partial nephrectomy (RPN). Both LPN and RPN can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of retroperitoneum cavity. However, with advanced surgical skills and thoughtful patient selection, RP approach may be associated with shorter OT, less EBL, shorter LOS compared with TP approach. Therefore, the investigators performed randomized control trial to compare the outcomes of the two approaches (TP-LPN or RPN vs RP-LPN or RPN). The purpose of this study To compare the treatment outcomes of the transperitoneal and retroperitoneal approach during LPN or RPN in treatment of small renal masses. Inclusion criteria During the study period, a small renal mass (less than 4cm, T1a stage) patients are going to underwent LPN or RPN. Exclusion criteria Patients who underwent radical nephrectomy Patients with bilateral renal masses Patients with a solitary kidney Patients reject a written informed consent Pregnancy The number of target subjects More than 106 patients who meet the inclusion criteria

Official Title
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Comparison of Peri-operative Outcomes of Laparoscopic or Robotic Partial Nephrectomy for Small Renal Mass: Transperitoneal vs Retroperitoneal Approach

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Procedure: Laparoscopic or robotic partial nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are going to undergo LPN or RPN with renal mass =<4cm Exclusion Criteria: Bilateral renal masses Solitary kidney Previous underwent nephrectomy refuse to be enrolled the study pregnancy
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transperitoneal approach<br>Laparoscopic or Robotic Partial Nephrectomy through transperitoneal approach | Procedure: Laparoscopic or robotic partial nephrectomy<br>* Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach<br>|
| Experimental: Retroperitoneal approach<br>Laparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach | Procedure: Laparoscopic or robotic partial nephrectomy<br>* Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time of partial nephrectomy | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Warm ischemic time (minutes) | Vessel clamping time during partial nephrectomy | Intraoperative | 
| Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification |  | from date of surgery, to 1 year postoperatively | 
| Change of differential glomerular filtration rate (dGFR) measured by renal scan |  | Preoperative dGFR and postoperative 1 year | 
| Overall disease-free survival time (month) | Disease free means no local recurrence, no metastasis. | from date of surgery, to 1 year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robot; Laparoscopic, Partial nephrectomy, Transperitoneal, Retroperitoneal, Laparoscopic Surgery, Surgical Procedures, Robotic, Nephrectomy