Clinical Trial

Donor Outcomes Following Hand-Assisted and Robotic Living Donor Nephrectomy: a Retrospective Review

Recruiting
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Record status
This record was last updated November 20, 2024 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2019-11-27; most recent amendment 2024-11-18.
Status change: Not Yet Recruiting → Recruiting 2019-12-30
Trial Details
NCT Number NCT04182607
Lead Sponsor Methodist Health System
Conditions Transplant, Kidney Diseases
Enrollment 240 participants
Start Date 2019-11-06
Primary Completion 2025-11 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2024-11-20