Clinical Trials Directory

Trials / Completed

CompletedNCT01236326

Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
105 (actual)
Sponsor
Weill Medical College of Cornell University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoendoscopic single site donor nephrectomyPatients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
PROCEDUREConventional laparoscopic donor nephrectomyPatients randomized to this arm will undergo conventional laparoscopic donor nephrectomy

Timeline

Start date
2010-11-01
Primary completion
2013-06-01
Completion
2013-10-01
First posted
2010-11-08
Last updated
2019-06-12
Results posted
2015-08-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01236326. Inclusion in this directory is not an endorsement.