Donor Outcomes Following Hand-Assisted And Robotic Living Donor Nephrectomy: A Retrospective Review

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: November 2020

Detailed Description

This is a retrospective, single-center cohort study. Clinical data will be collected from electronic medical records (EMRs) on donors and recipients who underwent a minimally invasive kidney transplantation procedure. Data from all patients who had a hand-assisted or robotic minimally invasive kidney transplantation procedure at Methodist Dallas Medical Center (MDMC) between January 2006 and November 2019 will be included in the study.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Patient demographics
    • Time Frame: between January 2006 and November 2019
    • Patient demographics of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
  • side of kidney transplantation (left versus right)
    • Time Frame: between January 2006 and November 2019
    • side of kidney transplantation of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
  • operating room (OR) time
    • Time Frame: between January 2006 and November 2019
    • operating room (OR) time of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
  • warm ischemia time
    • Time Frame: between January 2006 and November 2019
    • warm ischemia time of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
  • estimated blood loss (EBL)
    • Time Frame: between January 2006 and November 2019
    • estimated blood loss (EBL) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
  • complications
    • Time Frame: between January 2006 and November 2019
    • complications of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
  • hospital length of stay (LOS)
    • Time Frame: between January 2006 and November 2019
    • hospital length of stay (LOS) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
  • 30-day readmissions
    • Time Frame: between January 2006 and November 2019
    • 30-day readmissions of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
  • BMI
    • Time Frame: between January 2006 and November 2019
    • BMI of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
  • hospital-based charges/costs
    • Time Frame: between January 2006 and November 2019
    • hospital-based charges/costs of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
  • creatinine levels at discharge
    • Time Frame: between January 2006 and November 2019
    • creatinine levels at discharge of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

Participating in This Clinical Trial

Inclusion Criteria

  • ≥ 18 years of age
  • Kidney donors and recipients who underwent a hand-assisted or robotic kidney transplant

Exclusion Criteria

  • Patients that do not meet the Study Inclusion Criteria laid out above

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Methodist Health System
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alejandro Mejia, MD, Principal Investigator, The Liver Institute at Methodist Dallas Medical Center
  • Overall Contact(s)
    • Crystee Cooper, DHEd, 214-947-1285, CrysteeCooper@mhd.com

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