RAKT OUTCOME ANALYSIS

March 13, 2024 updated by: Seoul National University Hospital

ROBOT-ASSISTED KIDNEY TRANSPLANTATION VERSUS OPEN KIDNEY TRANSPLANTATION: a COMPARISON USING PROPENSITY SCORE MATCHING

The goal of this observational study is to compare outcomes of robot-assisted kidney transplantation and open kidney transplantation. The main questions are

- comprehensively analyze our early experience of robot-assisted kidney transplant patients and compare the results with those of open kidney transplant patients

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

200

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study includes patients received kidney-only transplants between Jan 2018 and Jan 2024 in Seoul National University Hospital.

Description

Inclusion Criteria:

  • Patients received kidney transplantation in SeoulNUH between Jan 2018 and Jan 2024

Exclusion Criteria:

  • patients with multi-organ transplant
  • patients with missing operative data

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
RAKT
robot-assisted kidney transplant patients
OKT
open kidney transplant patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
learning curve
Time Frame: transplantation to 6 months post-transplant
The Shewhart control chart and cumulative sum (CUSUM) analysis were used to evaluate technical outcomes and learning curve of RAKT based on RT, NAT, venous anastomosis and arterial anastomosis times
transplantation to 6 months post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal function
Time Frame: transplantation to 6 months post-transplant
This study will compare estimated glomerular filtration rate and graft survival rate between groups
transplantation to 6 months post-transplant

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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)

August 21, 2021

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RAKT Version 1.0

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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