Donor Outcomes Following Hand-Assisted and Robotic Living Donor Nephrectomy: a Retrospective Review
- Conditions
- TransplantKidney Diseases
- Interventions
- Procedure: kidney transplant
- Registration Number
- NCT04182607
- Lead Sponsor
- Methodist Health System
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- ≥ 18 years of age
- Kidney donors and recipients who underwent a hand-assisted or robotic kidney transplant
- Patients that do not meet the Study Inclusion Criteria laid out above
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description robotic kidney transplant kidney transplant Kidney donors and recipients who underwent a robotic kidney transplant hand-assisted kidney transplant kidney transplant Kidney donors and recipients who underwent a hand-assisted kidney transplant
- Primary Outcome Measures
Name Time Method hospital length of stay (LOS) (days from admit to discharge) 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).
BMI (kilogram per square meter (kg/m^2)) 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).
estimated blood loss (EBL) (milliliters (mL)) 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).
hospital-based charges/costs 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).
Patient demographics between January 2006 and November 2019 Patient demographics of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Kidney Laterality between January 2006 and November 2019 A chart review of which kidney (left versus right) was donated
operating room (OR) time (minutes) 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).
warm ischemia time (minutes) 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).
complications (using Clavien-Dindo scale) 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).
30-day readmissions 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).
creatinine levels at discharge (milligrams per deciliter (mg/dL)) 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States