NCT00460889

Brief Summary

This study is designed to look at outcomes of patients who have undergone hand assisted laparoscopic donor nephrectomy versus totally laparoscopic donor nephrectomy.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

April 13, 2007

Last Update Submit

April 2, 2015

Conditions

Living Renal Donor

Keywords

hand assistlaparoscopyrenal donoroutcomes

Outcome Measures

Primary Outcomes (2)

  • Prevalence of postoperative comfort and hospital stay satisfaction with HALDN

    1 week

  • Prevalence of postoperative comfort and hospital stay satisfaction with LDN

    1 week

Interventions

donor nephrectomyPROCEDURE

The objective of this protocol is to look at the outcomes of laparoscopic donor nephrectomy performed by using hand assisted (HA)or entirely laparoscopic (LDN) surgical techniques. To define the advantages of each technique, we will use records of patients who underwent laparoscopic live kidney donation with HALDN.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical clinic

You may qualify if:

  • any person undergoing minimally invasive donor nephrectomy surgery at NewYork Hospital/Columbia.

You may not qualify if:

  • any person undergoing open donor nephrectomy surgery at NewYork Hospital/Columbia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Study Officials

  • Dennis L Fowler, MD

    Columbia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2007

First Posted

April 17, 2007

Study Start

October 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

US(1)