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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Transplant, Kidney Diseases

Intervention / Treatment
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* Procedure: kidney transplant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hand-assisted kidney transplant<br>Kidney donors and recipients who underwent a hand-assisted kidney transplant | Procedure: kidney transplant<br>* Clinical data will be collected from electronic medical records (EMRs) on donors and recipients who underwent a minimally invasive kidney transplantation procedure<br>* Other names: nephrectomy;|
| robotic kidney transplant<br>Kidney donors and recipients who underwent a robotic kidney transplant | Procedure: kidney transplant<br>* Clinical data will be collected from electronic medical records (EMRs) on donors and recipients who underwent a minimally invasive kidney transplantation procedure<br>* Other names: nephrectomy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney, transplant, nephrectomy