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

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 Overview

• Status: Recruiting
• Conditions: Kidney Diseases; Transplant
• Intervention / Treatment: Procedure: kidney transplant

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.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • The Liver Institute At Methodist Dallas Medical Center
      • Contact: Elaina Vivian, MPH; Phone Number: 214-933-6611; Email: ElainaVivian@mhd.com
      • Contact: Colette Ngo Ndjom, MS; Phone Number: 214-947-4681; Email: ColetteNgoNdjom@mhd.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hand-assisted kidney transplant; Kidney donors and recipients who underwent a hand-assisted kidney transplant	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; Other Names: nephrectomy
robotic kidney transplant; Kidney donors and recipients who underwent a robotic kidney transplant	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; Other Names: nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographics	Patient demographics of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).	between January 2006 and November 2019
Kidney Laterality	A chart review of which kidney (left versus right) was donated	between January 2006 and November 2019
operating room (OR) time (minutes)	operating room (OR) time (minutes) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).	between January 2006 and November 2019
warm ischemia time (minutes)	warm ischemia time (minutes) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).	between January 2006 and November 2019
estimated blood loss (EBL) (milliliters (mL))	estimated blood loss (EBL) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).	between January 2006 and November 2019
complications (using Clavien-Dindo scale)	complications (using Clavien-Dindo scale) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).	between January 2006 and November 2019
hospital length of stay (LOS) (days from admit to discharge)	hospital length of stay (LOS) (days from admit to discharge) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).	between January 2006 and November 2019
30-day readmissions	30-day readmissions of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).	between January 2006 and November 2019
BMI (kilogram per square meter (kg/m^2))	BMI (kilogram per square meter (kg/m^2)) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).	between January 2006 and November 2019
hospital-based charges/costs	hospital-based charges/costs of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).	between January 2006 and November 2019
creatinine levels at discharge (milligrams per deciliter (mg/dL))	creatinine levels at discharge (milligrams per deciliter (mg/dL)) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).	between January 2006 and November 2019

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Alejandro Mejia, MD, The Liver Institute At Methodist Dallas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: transplant; kidney; nephrectomy
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: 063.HPB.2019.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data will be accessed by the principal investigator and delegated staff only for the duration of the trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No