NCT06320821

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2021

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

2.8 years

First QC Date

March 13, 2024

Last Update Submit

March 13, 2024

Conditions

Kidney TransplantationRobotic Surgery

Outcome Measures

Primary Outcomes (1)

  • learning curve

    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 Outcomes (1)

  • renal function

    transplantation to 6 months post-transplant

Study Arms (2)

RAKT

robot-assisted kidney transplant patients

OKT

open kidney transplant patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 20, 2024

Study Start

August 21, 2021

Primary Completion

May 30, 2024

Study Completion

August 30, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations

KR(1)