Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation
NCT01236326 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2019-06-12
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
- Living Donors
- Nephrectomy
- Kidney Transplantation
- Surgery, Laparoscopic
Interventions
- PROCEDURE
-
Laparoendoscopic single site donor nephrectomy
Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
- PROCEDURE
-
Conventional laparoscopic donor nephrectomy
Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
Sponsors & Collaborators
-
Weill Medical College of Cornell University
lead OTHER
Principal Investigators
-
Joseph J Del Pizzo, M.D. · Weill Medical College of Cornell University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2013-06-30
- Completion
- 2013-10-31
Countries
- United States
Study Locations
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