Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy

Not Applicable

• Conditions: Renal Cell Carcinoma
• Interventions: Procedure: Laparoscopic or robotic partial nephrectomy

• Registration Number: NCT02849119
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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

1. Patients who underwent radical nephrectomy

2. Patients with bilateral renal masses

3. Patients with a solitary kidney

4. Patients reject a written informed consent

5. Pregnancy

The number of target subjects More than 106 patients who meet the inclusion criteria

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2015-09
• Study Start: 2016-01
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-29
• Last Update Posted: 2016-07-29
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Patients are going to undergo LPN or RPN with renal mass =<4cm

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Exclusion Criteria

• Bilateral renal masses Solitary kidney Previous underwent nephrectomy refuse to be enrolled the study pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transperitoneal approach	Laparoscopic or robotic partial nephrectomy	Laparoscopic or Robotic Partial Nephrectomy through transperitoneal approach
Retroperitoneal approach	Laparoscopic or robotic partial nephrectomy	Laparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach

Primary Outcome Measures

Name	Time	Method
Operative time	Intraoperative	Operative time of partial nephrectomy

Secondary Outcome Measures

Name	Time	Method
Warm ischemic time (minutes)	Intraoperative	Vessel clamping time during partial nephrectomy
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)	from date of surgery, to 1 year postoperatively	Disease free means no local recurrence, no metastasis.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of