Kidney TransplantationNCT06320821
RAKT OUTCOME ANALYSIS
An observational study of Kidney Transplantation and Robotic Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplantation, Robotic Surgery
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Aug 2021to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study includes patients received kidney-only transplants between Jan 2018 and Jan 2024 in Seoul National University Hospital.
Who may be able to join
- Patients received kidney transplantation in SeoulNUH between Jan 2018 and Jan 2024
Who cannot join
- patients with multi-organ transplant
- patients with missing operative data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Kidney Transplantation, Robotic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RAKT | robot-assisted kidney transplant patients | |
| OKT | open kidney transplant patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: transplantation to 6 months post-transplant
Secondary outcomes (1)
renal function
This study will compare estimated glomerular filtration rate and graft survival rate between groups
Measured: transplantation to 6 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start21 Aug 2021
- Primary completion30 May 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320821
- Sponsor's protocol ID
- RAKT Version 1.0
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBOT-ASSISTED KIDNEY TRANSPLANTATION VERSUS OPEN KIDNEY TRANSPLANTATION: a COMPARISON USING PROPENSITY SCORE MATCHING
- ClinicalTrials.gov ID
- NCT06320821
- Acronym / sponsor ID
- RAKT Version 1.0
- Conditions
- Kidney Transplantation, Robotic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAKT | – | –robot-assisted kidney transplant patients |
| OKT | – | –open kidney transplant patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study includes patients received kidney-only transplants between Jan 2018 and Jan 2024 in Seoul National University Hospital.
Key inclusion criteria (1 listed)
- Patients received kidney transplantation in SeoulNUH between Jan 2018 and Jan 2024
Key exclusion criteria (2 listed)
- patients with multi-organ transplant
- patients with missing operative data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
renal function
Time frame: transplantation to 6 months post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Robotic Surgery, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
learning curve (time frame: transplantation to 6 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.