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NCT06287008 Clinical Trial

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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06287008
Other study ID # 2023-0085
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date January 31, 2024

Study information
Verified date February 2024
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 239
Est. completion date January 31, 2024
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Graft survival allograft (kidney) survival 1 year post-operative
Primary renal function renal function measured in terms of eGFR (Estimated Glomerular Filtration Rate) 1 year post-operative
Secondary . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies 1 year post-operative
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