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

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182607
• Other study ID #: 063.HPB.2019.D
• Status: Recruiting
• Start date: November 6, 2019
• Est. completion date: November 2022

Study information

• Verified date: December 2021
• Source: Methodist Health System
• Contact: Crystee Cooper, DHEd
• Phone: 214-947-1280
• Email: clinicalresearch[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Transplant

Intervention

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

Locations

Country	Name	City	State
United States	The Liver Institute at Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Kidney Laterality	A chart review of which kidney (left versus right) was donated	between January 2006 and November 2019
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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