Trial record 5 of 60 for:    "Living Donors" | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by Weill Medical College of Cornell University
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01236326
First received: November 4, 2010
Last updated: February 18, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236326

Contacts
Contact: Joseph J Del Pizzo, M.D. (212) 746-5250 jod2009@med.cornell.edu

Locations
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.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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 July 28, 2014