Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02849119
• Other study ID #: 2015-03-068-002
• Status: Recruiting
• Phase: N/A
• First received: June 28, 2016
• Last updated: July 26, 2016
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: September 2015
• Source: Samsung Medical Center
• Contact: Seongil Seo, MD
• Phone: 82-10-9933-3556
• Email: siseo[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Procedure:
• Laparoscopic or robotic partial nephrectomy
Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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