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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMethodist Health System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • kidney transplant

    Procedure/Surgery

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

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: hand-assisted kidney transplant1 intervention
Group B: robotic kidney transplant1 intervention

Trial outcomes

Primary outcomes

1

Patient demographics

Patient demographics of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

Time frame
between January 2006 and November 2019
2

Kidney Laterality

A chart review of which kidney (left versus right) was donated

Time frame
between January 2006 and November 2019
3

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).

Time frame
between January 2006 and November 2019
4

warm ischemia time (minutes)

warm ischemia time (minutes) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

Time frame
between January 2006 and November 2019

Secondary outcomes

Other outcomes

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