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Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy

Primary Purpose

Renal Cell Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic or robotic partial nephrectomy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Robot; Laparoscopic, Partial nephrectomy, Transperitoneal, Retroperitoneal, Laparoscopic Surgery, Surgical Procedures, Robotic, Nephrectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Transperitoneal approach

Retroperitoneal approach

Arm Description

Laparoscopic or Robotic Partial Nephrectomy through transperitoneal approach

Laparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach

Outcomes

Primary Outcome Measures

Operative time
Operative time of partial nephrectomy

Secondary Outcome Measures

Warm ischemic time (minutes)
Vessel clamping time during partial nephrectomy
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification
Change of differential glomerular filtration rate (dGFR) measured by renal scan
Overall disease-free survival time (month)
Disease free means no local recurrence, no metastasis.

Full Information

First Posted
June 28, 2016
Last Updated
July 26, 2016
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02849119
Brief Title
Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy
Official Title
Comparison of Peri-operative Outcomes of Laparoscopic or Robotic Partial Nephrectomy for Small Renal Mass: Transperitoneal vs Retroperitoneal Approach
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Robot; Laparoscopic, Partial nephrectomy, Transperitoneal, Retroperitoneal, Laparoscopic Surgery, Surgical Procedures, Robotic, Nephrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transperitoneal approach
Arm Type
Experimental
Arm Description
Laparoscopic or Robotic Partial Nephrectomy through transperitoneal approach
Arm Title
Retroperitoneal approach
Arm Type
Experimental
Arm Description
Laparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic or robotic partial nephrectomy
Intervention Description
Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach
Primary Outcome Measure Information:
Title
Operative time
Description
Operative time of partial nephrectomy
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Warm ischemic time (minutes)
Description
Vessel clamping time during partial nephrectomy
Time Frame
Intraoperative
Title
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification
Time Frame
from date of surgery, to 1 year postoperatively
Title
Change of differential glomerular filtration rate (dGFR) measured by renal scan
Time Frame
Preoperative dGFR and postoperative 1 year
Title
Overall disease-free survival time (month)
Description
Disease free means no local recurrence, no metastasis.
Time Frame
from date of surgery, to 1 year postoperatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seongil Seo, MD
Phone
82-10-9933-3556
Email
siseo@skku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Inhyuck Gong, Doctor
Phone
82-10-3110-2791
Email
kornumber1@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seongil Seo, MD
Organizational Affiliation
Urology department of Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seongil Seo, MD
Phone
82-10-9933-3556
Email
siseo@skku.edu
First Name & Middle Initial & Last Name & Degree
Inhyuck Gong, doctor
Phone
82-10-3110-2791
Email
kornumber1@naver.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy

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