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

NCT ID: NCT04182607

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-06

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Transplant Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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hand-assisted kidney transplant

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

kidney transplant

Intervention Type PROCEDURE

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

robotic kidney transplant

Kidney donors and recipients who underwent a robotic kidney transplant

kidney transplant

Intervention Type PROCEDURE

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

Interventions

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kidney transplant

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

Intervention Type PROCEDURE

Other Intervention Names

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nephrectomy

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years of age
* Kidney donors and recipients who underwent a hand-assisted or robotic kidney transplant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alejandro Mejia, MD

Role: PRINCIPAL_INVESTIGATOR

The Liver Institute at Methodist Dallas Medical Center

Locations

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The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Crystee Cooper, DHEd

Role: CONTACT

214-947-1280

Zaid Haddadin, MS

Role: CONTACT

214-947-1280

Facility Contacts

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Elaina Vivian, MPH

Role: primary

214.933.6611

Colette Ngo Ndjom, MS

Role: backup

214-947-4681

Alejandro Mejia, MD

Role: backup

Other Identifiers

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063.HPB.2019.D

Identifier Type: -

Identifier Source: org_study_id

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