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

  • France
      • Nice, France, 06003
        • Chu de Nice

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.

Sponsor

Centre Hospitalier Universitaire de Nice

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.

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