NCT00100516

Brief Summary

This study will evaluate the differences between open surgical kidney donation and laparoscopic kidney donation on kidney donors and recipients. Both procedures are standard surgeries used to remove kidneys for donation, and they are done equally often. Open surgical kidney donation involves removing the donor kidney through a 3- to 5-inch surgical incision. Laparoscopic donation involves making several small holes in the skin and removing the kidney through a larger hole, while directly watching the kidney with a camera. The study will correlate the effects of both procedures with donor and recipient kidney function, urine output, post-operative pain, and return to work after surgery. Adults without kidney disease who are willing to donate a kidney to a patient enrolled in a clinical transplant protocol at the NIH Clinical Center may be eligible for this study. Donors and recipients must be enrolled in the NIDDK protocol, Live Donor Renal Donation for Allotransplantation (protocol #99-DK-0107). Donors and patients undergo the following procedures:

  • Infrared imaging (measurement of small differences in temperature using a special camera) during surgery to look at blood flow to the kidney during the operation (both donor and recipient surgical procedures). The pictures provide images of the blood vessels in the kidney and measure how the blood flow changes.
  • Kidney biopsy (removal of a small piece of kidney tissue). The patient's failed kidney is biopsied once during transplant surgery when it is removed. The donor's kidney is biopsied twice - once during surgery to remove the organ from the donor and again after transplant into the recipient.
  • Evaluations after surgery of post-operative urine output, blood pressure, and pain, and length of hospital stay and return to work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2004

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 31, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2005

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2008

Completed
Last Updated

July 2, 2017

Status Verified

June 17, 2008

First QC Date

December 31, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

RenalAllograftsNephrectomyPneumoperitoneumLaparoscopICKidney Donation

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients enrolled in the Live Donor Renal Donation for Allotransplantation 99-DK-0107.

You may not qualify if:

  • Patients ineligible for this protocol will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Tarantino A. Why should we implement living donation in renal transplantation? Clin Nephrol. 2000 Apr;53(4):suppl 55-63.

    PMID: 10809438BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 31, 2004

First Posted

January 3, 2005

Study Start

December 23, 2004

Study Completion

June 17, 2008

Last Updated

July 2, 2017

Record last verified: 2008-06-17

Locations