Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy

July 26, 2016 updated by: Samsung Medical Center

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Transperitoneal approach
Laparoscopic or Robotic Partial Nephrectomy through transperitoneal approach
Procedure: Laparoscopic or robotic partial nephrectomy
Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach
EXPERIMENTAL: Retroperitoneal approach
Laparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach
Procedure: Laparoscopic or robotic partial nephrectomy
Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Intraoperative
Operative time of partial nephrectomy
Intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Study Chair: Seongil Seo, MD, Urology department of Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

January 1, 2017

Study Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (ESTIMATE)

July 29, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-03-068-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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