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

February 29, 2024 updated by: Sei Won Lee, Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

239

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

study includes 210 patients who undergo ABOi-open kidney transplantation and 29 who undergo ABOi-robot assisted kidney transplantation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OKT
patients who underwent "open kidney transplantation"
RAKT
patients who underwent "robot-assisted kidney transplantation"
Procedure: robot-assisted kidney transplantation
The interventional surgery is a robot-assisted kidney transplantation and its efficacy will be measured against that of open kidney transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft survival
Time Frame: 1 year post-operative
allograft (kidney) survival
1 year post-operative
renal function
Time Frame: 1 year post-operative
renal function measured in terms of eGFR (Estimated Glomerular Filtration Rate)
1 year post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
. 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
1 year post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

February 24, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-0085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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