Kidney Transplant FailureIMPACTNCT05200949
SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS
An observational study of Kidney Transplant Failure, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Kidney transplantation (KT) failure could be due to surgery dependent factors and particularly surgeon's experience. Objective: To assess the impact of the surgeon's experience on the post-operative outcomes to know if it safe for young surgeons to perform it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure
- What is being tested?
- Kidney transplant
- Type of treatment
- Surgery or procedure
- How many people
- 303 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2013to 31 Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patient who was treated with a kidney transplantation in CHU of Nice
Who may be able to join
- Patients who underwent Kidney Transplant in CHU of Nice
- Patient for whom a minimum of 12 months follow up is possible.
Who cannot join
- Patients who underwent a dual Kidney Transplant or a multi-organ transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMPACT OF SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS
Kidney transplantation (KT) failure could be due to surgery dependent factors and particularly surgeon's experience.
Objective: To assess the impact of the surgeon's experience on the post-operative outcomes to know if it safe for young surgeons to perform it.
- Conditions
- Kidney Transplant Failure
- Being tested
- Kidney transplant
- Keywords
- Transplant, Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney transplantProcedure or surgery
Transplant surgery of Kidney
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication post surgery
complication occurrence using the Clavien Dindo score
Measured: 1 month after transplant
Secondary outcomes (1)
function of the transplanted kidney
concentration of the creatininemia
Measured: within 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Jan 2013
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200949
- Sponsor's protocol ID
- 22Uro01
- Acronym
- IMPACT
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing data plan was established.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS
- ClinicalTrials.gov ID
- NCT05200949
- Acronym / sponsor ID
- IMPACT / 22Uro01
- Conditions
- Kidney Transplant Failure
- Keywords
- Transplant, Kidney
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 21 Jan 2022 (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.
Kidney transplantation (KT) failure could be due to surgery dependent factors and particularly surgeon's experience.
Objective: To assess the impact of the surgeon's experience on the post-operative outcomes to know if it safe for young surgeons to perform it.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patient who was treated with a kidney transplantation in CHU of Nice
Key inclusion criteria (2 listed)
- Patients who underwent Kidney Transplant in CHU of Nice
- Patient for whom a minimum of 12 months follow up is possible.
Key exclusion criteria (1 listed)
- Patients who underwent a dual Kidney Transplant or a multi-organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney transplantTransplant surgery of Kidney | Procedure or surgery | – |
Primary outcome
Complication post surgery
Time frame: 1 month after transplant
complication occurrence using the Clavien Dindo score
1 secondary outcome
function of the transplanted kidney
Time frame: within 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No. No sharing data plan was established.
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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 Transplant Failure, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Feb 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complication post surgery (time frame: 1 month after 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 7 Feb 2022.