Transperitoneal vs Retroperitoneal Laparoscopic or Roboti... | NCT02849119

Studies
Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy

NCT02849119

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jul 29, 2016Estimated

Enrollment

106Estimated

Phase

Not Applicable

Conditions

Renal Cell Carcinoma

Interventions

Laparoscopic or robotic partial nephrectomy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jan 2017Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Jun 28, 2016

First Submission Date that Met QC Criteria

Jul 26, 2016

First Posted Date

Jul 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2016

Last Update Posted Date

Jul 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transperitoneal approach	Experimental	Laparoscopic or Robotic Partial Nephrectomy through transperitoneal approach	Procedure: Laparoscopic or robotic partial nephrectomy
Retroperitoneal approach	Experimental	Laparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach	Procedure: Laparoscopic or robotic partial nephrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic or robotic partial nephrectomy	Procedure	Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Warm ischemic time (minutes)	Vessel clamping time during partial nephrectomy	Intraoperative
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seongil Seo, MD	Contact	82-10-9933-3556		siseo@skku.edu
Inhyuck Gong, Doctor	Contact	82-10-3110-2791		kornumber1@naver.com

Overall Officials

Name	Affiliation	Role
Seongil Seo, MD	Urology department of Samsung Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul	Seoul	06351	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010535	Laparoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided