Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Living Donors Nephrectomy Kidney Transplantation Surgery, Laparoscopic |
Procedure: Laparoendoscopic single site donor nephrectomy Procedure: Conventional laparoscopic donor nephrectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- The primary endpoint of the study will be patient self-reported "return to 100%", as measured by the number of days post-surgery that the patient reports his or her return to 100% functioning capacity. [ Time Frame: 12 months ] [ Designated as safety issue: No ]The mean and median number of days required for "return to 100% capacity" in each surgical group will be computed and compared.
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: LESS-DN |
Procedure: Laparoendoscopic single site donor nephrectomy
Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
|
| Active Comparator: Conventional LDN |
Procedure: Conventional laparoscopic donor nephrectomy
Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study.
Exclusion Criteria:
- There are no exclusion criteria.
Contacts and Locations| Contact: Joseph J Del Pizzo, M.D. | (212) 746-5250 | jod2009@med.cornell.edu |
| United States, New York | |
| NewYork-Presbyterian Hospital/Weill Cornell Medical Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Marian Charlton, RN, CCTC 212-746-1742 mbc2001@nyp.org | |
| Principal Investigator: Joseph J Del Pizzo, M.D. | |
| Principal Investigator: | Joseph J Del Pizzo, M.D. | Weill Medical College of Cornell University |
More Information
No publications provided
| Responsible Party: | Joseph J. Del Pizzo, M.D., Associate Professor of Urology and Surgery, Weill Cornell Medical College |
| ClinicalTrials.gov Identifier: | NCT01236326 History of Changes |
| Other Study ID Numbers: | 1009011249 |
| Study First Received: | November 4, 2010 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 19, 2013