NCT04182607 Donor Outcomes Following Hand-Assisted and Robotic Living Donor Nephrectomy: a Retrospective Review
| NCT ID | NCT04182607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Methodist Health System |
| Condition | Transplant |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2019-11-06 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2019-11-06 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Alejandro Mejia, MD
PRINCIPAL INVESTIGATOR
The Liver Institute at Methodist Dallas Medical Center
Frequently Asked Questions
Who can join the NCT04182607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04182607 currently recruiting?
Yes, NCT04182607 is actively recruiting participants. Contact the research team at clinicalresearch@mhd.com for enrollment information.
Where is the NCT04182607 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT04182607 clinical trial?
NCT04182607 is sponsored by Methodist Health System. The principal investigator is Alejandro Mejia, MD at The Liver Institute at Methodist Dallas Medical Center. The trial plans to enroll 240 participants.