Donor Outcomes Following Hand-Assisted and Robotic Living Donor Nephrectomy: a Retrospective Review
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- hospital length of stay (LOS) (days from admit to discharge)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Kidney donors and recipients who underwent a hand-assisted or robotic kidney transplant
排除标准
- •Patients that do not meet the Study Inclusion Criteria laid out above
结局指标
主要结局
hospital length of stay (LOS) (days from admit to discharge)
时间窗: 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).
BMI (kilogram per square meter (kg/m^2))
时间窗: 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).
estimated blood loss (EBL) (milliliters (mL))
时间窗: 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).
hospital-based charges/costs
时间窗: 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).
Patient demographics
时间窗: between January 2006 and November 2019
Patient demographics of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Kidney Laterality
时间窗: between January 2006 and November 2019
A chart review of which kidney (left versus right) was donated
operating room (OR) time (minutes)
时间窗: 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).
warm ischemia time (minutes)
时间窗: 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).
complications (using Clavien-Dindo scale)
时间窗: 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).
30-day readmissions
时间窗: 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).
creatinine levels at discharge (milligrams per deciliter (mg/dL))
时间窗: 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).
次要结局
未报告次要终点