CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
Laparoendoscopic single site donor nephrectomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01236326
NCT01236326N/ACompleted

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

Weill Medical College of Cornell University·interventional·Posted Nov 8, 2010·Updated Jun 12, 2019

In Brief

A clinical study evaluating Laparoendoscopic single site donor nephrectomy and Conventional laparoscopic donor nephrectomy for Living Donors and 3 related conditions. Completed, enrolled 105 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2010
Enrollment StartNov 1, 2010
Primary CompletionJun 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.7 years ago

Interventions

Laparoendoscopic single site donor nephrectomyprocedure

Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy

Conventional laparoscopic donor nephrectomyprocedure

Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy