- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02849119
Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy
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
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
- 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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Seongil Seo, MD
- Phone Number: 82-10-9933-3556
- Email: siseo@skku.edu
Study Contact Backup
- Name: Inhyuck Gong, doctor
- Phone Number: 82-10-3110-2791
- Email: kornumber1@naver.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- Seongil Seo, MD
- Phone Number: 82-10-9933-3556
- Email: siseo@skku.edu
-
Contact:
- Inhyuck Gong, doctor
- Phone Number: 82-10-3110-2791
- Email: kornumber1@naver.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
Sponsor
Investigators
- Study Chair: Seongil Seo, MD, Urology department of Samsung Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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