A Randomized, Prospective, Parallel Group Study of Conventional Laparoscopic Donor Nephrectomy (LDN) Versus Laparoendoscopic Single Site Donor Nephrectomy (LESS-DN) in Living Donor Kidney Transplantation
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10065 |
| Conditions: |
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Living Donors - Nephrectomy - Kidney Transplantation - Surgery, Laparoscopic |
| Purpose: |
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Laparoscopic nephrectomy (removal of the kidney) is the most common procedure for people
donating a kidney to be used for living donor kidney transplantation. Laparoscopic donor
nephrectomy (LDN) was a great advance in the field of living donor kidney transplantation
due to the many advantages it offers over open nephrectomy, including significantly shorter
hospitalization and recovery time, and significantly improved cosmetic result related to the
nephrectomy scar(s). More recently, a new procedure has been introduced to the field of
laparoscopic nephrectomy, called laparoendoscopic single site donor nephrectomy (LESS-DN).
In the LESS-DN procedure, a single natural orifice (the umbilicus or belly button) is used
as the single incision site through which the entire donor nephrectomy is performed. The
LESS-DN procedure may further decrease donor morbidity by further decreasing length of stay,
lessening recovery time, and improving satisfaction with the surgical scar. The
investigators propose to evaluate conventional LDN versus a LESS-DN in a randomized,
controlled trial in living kidney donors. The investigators will compare operative times
and intra-operative donor management, intra- and post-operative complications, pain scores,
analgesic requirements, length of stay, recovery parameters, surgical scar satisfaction, and
function and survival of the transplanted kidney for the two groups of subjects: (1) the
group that has the conventional laparoscopic donor nephrectomy; and, (2) the group that has
the laparoendoscopic single site donor nephrectomy.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- All patients scheduled to undergo laparoscopic living donor nephrectomy will be
eligible for the study.
Exclusion Criteria:
- There are no exclusion criteria.
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| NCT ID: |
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NCT01236326 |
| Primary Contact: |
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Principal Investigator
Joseph J Del Pizzo, M.D.
Weill Medical College of Cornell University
Joseph J Del Pizzo, M.D.
Phone: (212) 746-5250
Email: jod2009@med.cornell.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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New York, New York 10065
United States
Marian Charlton, RN, CCTC
Phone: 212-746-1742
Email: mbc2001@nyp.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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