Donor Outcomes Following Hand-Assisted and Robotic Living Donor Nephrectomy: a Retrospective Review

Part of paid clinical trials in Dallas, Texas.

Sponsor
Methodist Health System
Study ID
NCT04182607
Status
Recruiting

Conditions

  • Kidney Diseases
  • Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • kidney transplant — PROCEDURE
    Clinical data will be collected from electronic medical records (EMRs) on donors and recipients who underwent a minimally invasive kidney transplantation procedure

Study Details

1.1. Background: Renal transplantation is the treatment of choice for eligible patients with end-stage renal disease. It provides better outcomes in terms of life expectancy and quality of life than dialysis (Liu, Narins, Maley, Frank, \& Lallas, 2012). Kidney transplants from living donors also have additional benefits in terms of graft function and survival compared to transplants from cadaver donors (Galvani et al., 2012). Living donor transplants provide an opportunity to have good quality grafts and to perform the procedure when the recipient is in an optimal clinical status (Creta et al., 2019). Laparoscopic donor nephrectomy was first introduced in 1995 and is currently accepted as the gold standard for kidney procurement from living donors. The first worldwide robotic assisted laparoscopic donor nephrectomy was performed in 2000 by Horgan et al. (Horgan et al., 2007). The main obstacle to living donation is the exposure of a healthy subject to the risks of a major surgical intervention. Therefore, efforts have been made to reduce complications and postoperative pain, achieve faster recovery, and minimize the surgical incisions. Minimally invasive procedures like hand-assisted and robotic approaches greatly enhance living donation rates, and in 2001 the number of living donors exceeded the number of cadaver donors (Horgan et al., 2007). 1.2. Aim(s)/Objective(s): The objective of this study is to compare intra- and postoperative patient outcomes of kidney donors following hand-assisted and robotic kidney transplants at a single center. 1.3. Rationale for the study: More research is needed regarding the differences between minimally invasive approaches to kidney transplantation.

Key Dates

Start date
Nov 6, 2019
Status verified
Sep 2024
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: hand-assisted kidney transplant
    Kidney donors and recipients who underwent a hand-assisted kidney transplant
  • Arm: robotic kidney transplant
    Kidney donors and recipients who underwent a robotic kidney transplant

Primary Outcome Measure

Patient demographics [ Time Frame: between January 2006 and November 2019 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Liver Institute at Methodist Dallas Medical CenterDallasTexas75203
Elaina Vivian, MPH
214.933.6611
Colette Ngo Ndjom, MS
214-947-4681
Alejandro Mejia, MD

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