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

Completed

• Conditions: Kidney Transplantation
• Interventions: Procedure: robot-assisted kidney transplantation

• Registration Number: NCT06287008
• Lead Sponsor: Asan Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2023-09-30
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-24
• Study First Submitted QC: 2024-02-24
• Study First Posted: 2024-02-29
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RAKT	robot-assisted kidney transplantation	patients who underwent "robot-assisted kidney transplantation"

Primary Outcome Measures

Name	Time	Method
renal function	1 year post-operative	renal function measured in terms of eGFR (Estimated Glomerular Filtration Rate)
Graft survival	1 year post-operative	allograft (kidney) survival

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of