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临床试验/NCT06287008
NCT06287008已完成不适用

A Comparative Study on Outcomes of ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery: A Retrospective Cohort Study

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
239
试验地点
1
主要终点
renal function

研究概览

简要总结

While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. This study aims to compare ABO-i KT outcomes between RAKT and OKT.

The study utilized data from 29 ABO-i RAKT and 210 ABO-i OKT cases performed at Asan Medical Center from October 2020 to February 2023. Univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (BPAR), de novo donor-specific antibodies (DSA), and overall graft failure.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient eligible for living donor ABO incompatible kidney transplantation
  • Presenting an IsoAgglutinin immunoglobulin G titer (anti-A-B) between 1/8 and 1/128 before operation
  • Patient older than 18 years and young than 80 years
  • Patient able to sign an informed consent form

排除标准

  • Patient with comorbidities or hypersensitivity that prevent desensitization protocols
  • Women who are pregnant, or who may become pregnant or breastfeeding women
  • Subjects under legal protection
  • Subjects participating in another interventional research protocol or in an exclusion period from another interventional research protocolPatient affiliated with a social security scheme

结局指标

主要结局

renal function

时间窗: 1 year post-operative

renal function measured in terms of eGFR (Estimated Glomerular Filtration Rate)

Graft survival

时间窗: 1 year post-operative

allograft (kidney) survival

次要结局

  • . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies(1 year post-operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sei Won Lee

Clinical Professor

Asan Medical Center

研究点 (1)

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