NCT01093079

Brief Summary

Partial Nephrectomy is the standard care for small (\<4 cm) renal tumors. Despite the expanding use of laparoscopic approach, debate exist regarding the short and long term outcomes compared to the open approach. Our goal is to perform a prospective randomized trial to compare these methods

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

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

September 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
Last Updated

March 25, 2010

Status Verified

July 1, 2009

First QC Date

March 24, 2010

Last Update Submit

March 24, 2010

Conditions

TumorNephrectomyLaparoscopy

Keywords

Renal tumor, RCC, Partial nephrectomy, Laparoscopy

Study Arms (2)

Laparoscopic partial nephrectomy

Procedure: Laparoscopic partial nephrectomy

Open Partial nephrectomy

Procedure: Open partial nephrectomy

Interventions

Laparoscopic partial nephrectomyPROCEDURE

Laparoscopic partial nephrectomy

Laparoscopic partial nephrectomy
Open partial nephrectomyPROCEDURE

Open partial nephrectomy

Open Partial nephrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to partial nephrectomy due to renal lesion , suspected to be a tumor

You may qualify if:

  • patients referred to partial nephrectomy

You may not qualify if:

  • Contra-indication for laparocopic surgery
  • Complexed , large tumors, single kidney, chronic renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin medical center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shay Golan, MD

CONTACT

972-50-7447573shaygo1@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 25, 2010

Study Start

September 1, 2009

Last Updated

March 25, 2010

Record last verified: 2009-07

Locations

IL(1)