Recruiting

Hand-Assisted & Robotic Nephrectomy

Sponsor:

Methodist Health System

Code:

NCT04182607

Conditions

Transplant

Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

kidney transplant

Study Details

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.

Conditions

Transplant

Kidney Diseases

Study ID

NCT04182607

Start date

Nov 6, 2019

Status verified date

Sep, 2024

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

hand-assisted kidney transplant

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

robotic kidney transplant

Kidney donors and recipients who underwent a robotic kidney transplant

Interventions

kidney transplant

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

Primary outcome measure

  • Patient demographics [ Time Frame: between January 2006 and November 2019 ]
  • Kidney Laterality [ Time Frame: between January 2006 and November 2019 ]
  • operating room (OR) time (minutes) [ Time Frame: between January 2006 and November 2019 ]
  • warm ischemia time (minutes) [ Time Frame: between January 2006 and November 2019 ]
  • estimated blood loss (EBL) (milliliters (mL)) [ Time Frame: between January 2006 and November 2019 ]
  • complications (using Clavien-Dindo scale) [ Time Frame: between January 2006 and November 2019 ]
  • hospital length of stay (LOS) (days from admit to discharge) [ Time Frame: between January 2006 and November 2019 ]
  • 30-day readmissions [ Time Frame: between January 2006 and November 2019 ]
  • BMI (kilogram per square meter (kg/m^2)) [ Time Frame: between January 2006 and November 2019 ]
  • hospital-based charges/costs [ Time Frame: between January 2006 and November 2019 ]
  • creatinine levels at discharge (milligrams per deciliter (mg/dL)) [ Time Frame: between January 2006 and November 2019 ]

Central Contacts and Locations

Central contacts

Locations

The Liver Institute at Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

More Information

Sponsor

Methodist Health System

Last update posted

Nov 20, 2024

Last verified

Sep, 2024

Keywords

  • kidney
  • transplant
  • nephrectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Methodist Health System on 2024-11-20.