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OpenTrials
Completed

NCT Number: NCT06287008

ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

robot-assisted kidney transplantation

Procedure

The interventional surgery is a robot-assisted kidney transplantation and its efficacy will be measured against that of open kidney transplantation

Primary outcomes

  1. Graft survival

    Time frame: 1 year post-operative

    allograft (kidney) survival

  2. renal function

    Time frame: 1 year post-operative

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

Secondary outcomes

  1. . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies

    Time frame: 1 year post-operative

    . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies

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Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Feb 29, 2024
Registry last updated
Mar 1, 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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