NCT02849119

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 29, 2016

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

June 28, 2016

Last Update Submit

July 26, 2016

Conditions

Renal Cell Carcinoma

Keywords

Robot; LaparoscopicPartial nephrectomyTransperitonealRetroperitonealLaparoscopic SurgerySurgical Procedures, RoboticNephrectomy

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Operative time of partial nephrectomy

    Intraoperative

Secondary Outcomes (4)

  • Warm ischemic time (minutes)

    Intraoperative

  • Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification

    from date of surgery, to 1 year postoperatively

  • Change of differential glomerular filtration rate (dGFR) measured by renal scan

    Preoperative dGFR and postoperative 1 year

  • Overall disease-free survival time (month)

    from date of surgery, to 1 year postoperatively

Study Arms (2)

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

Laparoscopic or robotic partial nephrectomyPROCEDURE

Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach

Retroperitoneal approachTransperitoneal approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are going to undergo LPN or RPN with renal mass =\<4cm

You may not qualify if:

  • Bilateral renal masses Solitary kidney Previous underwent nephrectomy refuse to be enrolled the study pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Seongil Seo, MD

    Urology department of Samsung Medical Center

    STUDY CHAIR

Central Study Contacts

Seongil Seo, MD

CONTACT

82-10-9933-3556siseo@skku.edu

Inhyuck Gong, Doctor

CONTACT

82-10-3110-2791kornumber1@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 29, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 29, 2016

Record last verified: 2015-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)