Laparoscopic Versus Open Partial Nephrectomy - Surgical a... | NCT01093079

Studies
Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes

NCT01093079

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Mar 25, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Tumor
Nephrectomy
Laparoscopy

Interventions

Laparoscopic partial nephrectomy
Open partial nephrectomy

Countries

Israel

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

Jul 2009

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

Sep 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 24, 2010

First Submission Date that Met QC Criteria

Mar 24, 2010

First Posted Date

Mar 25, 2010Estimated

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

Mar 24, 2010

Last Update Posted Date

Mar 25, 2010Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparoscopic partial nephrectomy			Procedure: Laparoscopic partial nephrectomy
Open Partial nephrectomy			Procedure: Open partial nephrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic partial nephrectomy	Procedure	Laparoscopic partial nephrectomy	Laparoscopic partial nephrectomy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients referred to partial nephrectomy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shay Golan, MD	Contact	972-50-7447573		shaygo1@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin medical center	Recruiting	Petah Tikva			Israel

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
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