- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05200949
SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS (IMPACT)
January 24, 2022 updated by: Centre Hospitalier Universitaire de Nice
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
303
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
-
-
-
Nice, France, 06003
- CHU de NICE
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all patient who was treated with a kidney transplantation in CHU of Nice
Description
Inclusion Criteria:
- Patients who underwent Kidney Transplant in CHU of Nice
- Patient for whom a minimum of 12 months follow up is possible.
Exclusion Criteria:
- Patients who underwent a dual Kidney Transplant or a multi-organ transplant
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complication post surgery
Time Frame: 1 month after transplant
|
complication occurrence using the Clavien Dindo score
|
1 month after transplant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
function of the transplanted kidney
Time Frame: within 1 year after surgery
|
concentration of the creatininemia
|
within 1 year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2013
Primary Completion (Actual)
December 31, 2015
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
January 7, 2022
First Submitted That Met QC Criteria
January 7, 2022
First Posted (Actual)
January 21, 2022
Study Record Updates
Last Update Posted (Actual)
February 7, 2022
Last Update Submitted That Met QC Criteria
January 24, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 22Uro01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No sharing data plan was established.
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.