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

November 18, 2024 updated by: Methodist Health System

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

Intervention / Treatment

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 (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Recruiting
        • The Liver Institute at Methodist Dallas Medical Center
        • Contact:
        • Contact:
        • Contact:
          • Alejandro Mejia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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).
between January 2006 and November 2019
Kidney Laterality
Time Frame: between January 2006 and November 2019
A chart review of which kidney (left versus right) was donated
between January 2006 and November 2019
operating room (OR) time (minutes)
Time Frame: between January 2006 and November 2019
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)
Time Frame: between January 2006 and November 2019
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))
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).
between January 2006 and November 2019
complications (using Clavien-Dindo scale)
Time Frame: between January 2006 and November 2019
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)
Time Frame: between January 2006 and November 2019
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
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).
between January 2006 and November 2019
BMI (kilogram per square meter (kg/m^2))
Time Frame: between January 2006 and November 2019
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
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).
between January 2006 and November 2019
creatinine levels at discharge (milligrams per deciliter (mg/dL))
Time Frame: between January 2006 and November 2019
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

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Alejandro Mejia, MD, The Liver Institute at Methodist Dallas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2019

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

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)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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