We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236326
First Posted: November 8, 2010
Last Update Posted: August 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
November 4, 2010
November 8, 2010
July 29, 2015
August 26, 2015
August 26, 2015
November 2010
June 2013   (Final data collection date for primary outcome measure)
The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity. [ Time Frame: 1 year ]
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.
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 ]
The mean and median number of days required for "return to 100% capacity" in each surgical group will be computed and compared.
Complete list of historical versions of study NCT01236326 on ClinicalTrials.gov Archive Site
  • Days on Oral Pain Medication After Discharge [ Time Frame: 2 months ]
  • Days Before Going Back to Work [ Time Frame: 2 months ]
  • Days to Normal Day-to-day Activities [ Time Frame: 2 months ]
  • Recovered by 2 Months After Donation [ Time Frame: 2 months ]
Not Provided
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Living Donors
  • Nephrectomy
  • Kidney Transplantation
  • Surgery, Laparoscopic
  • 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
  • Active Comparator: LESS-DN
    Intervention: Procedure: Laparoendoscopic single site donor nephrectomy
  • Active Comparator: Conventional LDN
    Intervention: Procedure: Conventional laparoscopic donor nephrectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
October 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study.

Exclusion Criteria:

  • There are no exclusion criteria.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01236326
1009011249
No
Not Provided
Not Provided
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Joseph J Del Pizzo, M.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP