Clinical trial NCT04182607: Donor Outcomes Following Hand-Assisted and Robotic Living Donor Nephrectomy: a Retrospective Review
Official title: Donor Outcomes Following Hand-Assisted and Robotic Living Donor Nephrectomy: a Retrospective Review
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transplant
Kidney Diseases
Keywords: kidney
transplant
nephrectomy
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient demographics
timeFrame: between January 2006 and November 2019
measure: Kidney Laterality
timeFrame: between January 2006 and November 2019
measure: operating room (OR) time (minutes)
timeFrame: between January 2006 and November 2019
measure: warm ischemia time (minutes)
timeFrame: between January 2006 and November 2019
measure: estimated blood loss (EBL) (milliliters (mL))
timeFrame: between January 2006 and November 2019
measure: complications (using Clavien-Dindo scale)
timeFrame: between January 2006 and November 2019
measure: hospital length of stay (LOS) (days from admit to discharge)
timeFrame: between January 2006 and November 2019
measure: 30-day readmissions
timeFrame: between January 2006 and November 2019
measure: BMI (kilogram per square meter (kg/m^2))
timeFrame: between January 2006 and November 2019
measure: hospital-based charges/costs
timeFrame: between January 2006 and November 2019
measure: creatinine levels at discharge (milligrams per deciliter (mg/dL))
timeFrame: between January 2006 and November 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Liver Institute at Methodist Dallas Medical Center
name: Alejandro Mejia, MD
role: PRINCIPAL_INVESTIGATOR
References: