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

NCT ID: NCT06287008

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-01-31

Brief Summary

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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

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Conditions

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Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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OKT

patients who underwent "open kidney transplantation"

No interventions assigned to this group

RAKT

patients who underwent "robot-assisted kidney transplantation"

robot-assisted kidney transplantation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sei Won Lee

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim JM, Kwon HE, Ko Y, Jung JH, Kwon H, Kim YH, Shin S. A comparative study on outcomes of ABO-incompatible kidney transplants between robot-assisted vs. open surgery-propensity score-matched analysis: a retrospective cohort study. BMC Nephrol. 2024 Nov 14;25(1):410. doi: 10.1186/s12882-024-03842-1.

Reference Type DERIVED
PMID: 39543527 (View on PubMed)

Other Identifiers

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2023-0085

Identifier Type: -

Identifier Source: org_study_id

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