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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation; Nephrectomy; Living Donors; Surgery, Laparoscopic
• Intervention / Treatment: Procedure: Laparoendoscopic single site donor nephrectomy; Procedure: Conventional laparoscopic donor nephrectomy

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • NewYork-Presbyterian Hospital/Weill Cornell Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• There are no exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Days on Oral Pain Medication After Discharge	2 months
Days Before Going Back to Work	2 months
Days to Normal Day-to-day Activities	2 months
Recovered by 2 Months After Donation	2 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Joseph J Del Pizzo, M.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: November 4, 2010
• First Submitted That Met QC Criteria: November 5, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1009011249