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NCT Number: NCT04182607

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

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.

Recruiting

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Key information

Conditions

Transplant Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: nephrectomy

Primary outcomes

  1. Patient demographics

    Time frame: between January 2006 and November 2019

    Patient demographics of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

  2. Kidney Laterality

    Time frame: between January 2006 and November 2019

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

  3. operating room (OR) time (minutes)

    Time frame: between January 2006 and November 2019

    operating room (OR) time (minutes) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

  4. warm ischemia time (minutes)

    Time frame: between January 2006 and November 2019

    warm ischemia time (minutes) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

  5. estimated blood loss (EBL) (milliliters (mL))

    Time frame: between January 2006 and November 2019

    estimated blood loss (EBL) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

  6. complications (using Clavien-Dindo scale)

    Time frame: between January 2006 and November 2019

    complications (using Clavien-Dindo scale) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

  7. hospital length of stay (LOS) (days from admit to discharge)

    Time frame: between January 2006 and November 2019

    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).

  8. 30-day readmissions

    Time frame: between January 2006 and November 2019

    30-day readmissions of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

  9. BMI (kilogram per square meter (kg/m^2))

    Time frame: between January 2006 and November 2019

    BMI (kilogram per square meter (kg/m^2)) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

  10. hospital-based charges/costs

    Time frame: between January 2006 and November 2019

    hospital-based charges/costs of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).

  11. creatinine levels at discharge (milligrams per deciliter (mg/dL))

    Time frame: between January 2006 and November 2019

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Crystee Cooper, DHEd

CONTACT

[email protected]

214-947-1280

Zaid Haddadin, MS

CONTACT

[email protected]

214-947-1280

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2019
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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