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Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy

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ClinicalTrials.gov Identifier: NCT02849119
Recruitment Status : Unknown
Verified September 2015 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Procedure: Laparoscopic or robotic partial nephrectomy Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Peri-operative Outcomes of Laparoscopic or Robotic Partial Nephrectomy for Small Renal Mass: Transperitoneal vs Retroperitoneal Approach
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Operative time [ Time Frame: Intraoperative ]
    Operative time of partial nephrectomy


Secondary Outcome Measures :
  1. Warm ischemic time (minutes) [ Time Frame: Intraoperative ]
    Vessel clamping time during partial nephrectomy

  2. Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification [ Time Frame: from date of surgery, to 1 year postoperatively ]
  3. Change of differential glomerular filtration rate (dGFR) measured by renal scan [ Time Frame: Preoperative dGFR and postoperative 1 year ]
  4. Overall disease-free survival time (month) [ Time Frame: from date of surgery, to 1 year postoperatively ]
    Disease free means no local recurrence, no metastasis.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849119


Contacts
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Contact: Seongil Seo, MD 82-10-9933-3556 siseo@skku.edu
Contact: Inhyuck Gong, Doctor 82-10-3110-2791 kornumber1@naver.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Seongil Seo, MD    82-10-9933-3556    siseo@skku.edu   
Contact: Inhyuck Gong, doctor    82-10-3110-2791    kornumber1@naver.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Study Chair: Seongil Seo, MD Urology department of Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02849119     History of Changes
Other Study ID Numbers: 2015-03-068-002
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: September 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Samsung Medical Center:
Robot; Laparoscopic
Partial nephrectomy
Transperitoneal
Retroperitoneal
Laparoscopic Surgery
Surgical Procedures, Robotic
Nephrectomy
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases