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Идёт набор NCT04182607

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

— Наблюдательное Transplant Kidney Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: kidney transplant.
Кому может быть актуально
Состояния в реестре: Transplant, Kidney Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Patient demographics [Срок оценки: between January 2006 and November 2019]
  • Kidney Laterality [Срок оценки: between January 2006 and November 2019]
  • operating room (OR) time (minutes) [Срок оценки: between January 2006 and November 2019]
  • warm ischemia time (minutes) [Срок оценки: between January 2006 and November 2019]
  • estimated blood loss (EBL) (milliliters (mL)) [Срок оценки: between January 2006 and November 2019]
  • complications (using Clavien-Dindo scale) [Срок оценки: between January 2006 and November 2019]
  • hospital length of stay (LOS) (days from admit to discharge) [Срок оценки: between January 2006 and November 2019]
  • 30-day readmissions [Срок оценки: between January 2006 and November 2019]
  • BMI (kilogram per square meter (kg/m^2)) [Срок оценки: between January 2006 and November 2019]
  • hospital-based charges/costs [Срок оценки: between January 2006 and November 2019]

Критерии участия

Критерии включения

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

Критерии исключения

  • Patients that do not meet the Study Inclusion Criteria laid out above

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • The Liver Institute at Methodist Dallas Medical Center — Dallas

Идентификаторы

NCT: NCT04182607 · 063.HPB.2019.D

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗