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

NCT04182607 | Recruiting

• 1 other identifier: 063.HPB.2019.D
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

kidney; transplant; nephrectomy

Outcome Measures

Primary Outcomes (11)

• 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

• Kidney Laterality

  A chart review of which kidney (left versus right) was donated

  between January 2006 and November 2019

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

hand-assisted kidney transplant

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

Procedure: kidney transplant

robotic kidney transplant

Kidney donors and recipients who underwent a robotic kidney transplant

Procedure: kidney transplant

Interventions

kidney transplant PROCEDURE

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

Also known as: nephrectomy

hand-assisted kidney transplant; robotic kidney transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥ 18 years of age
• Kidney donors and recipients who underwent a hand-assisted or robotic kidney transplant

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Interventions

Kidney Transplantation; Nephrectomy

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Alejandro Mejia, MD

  The Liver Institute at Methodist Dallas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystee Cooper, DHEd

CONTACT

214-947-1280; clinicalresearch@mhd.com

Zaid Haddadin, MS

CONTACT

214-947-1280; clinicalresearch@mhd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: November 6, 2019
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)