Protocol DIVAT-Uro

NCT ID: NCT01280708

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1616 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-02

Study Completion Date

2013-12-31

Brief Summary

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The aim of project DIVAT-URO (Données Informatisées et Validées en Transplantation - Urology) is to organize a thematic network in urology traced on NetWork DIVAT to supplement the medical and biological data of DIVAT existing cohort with parameters of surgical transplantation of kidney and pancreas. These data will concern the transplantation itself and the events and complications related to surgery occurring throughout the follow-up. The collection will involve patients in the cohort DIVAT and future patients. This project will allow us to have the sufficiency of surgical transplantation by increasing the quantity and quality of information gathered thus avoiding the biases commonly upbraided against the retrospective studies. Finally, by supplementing it with new parameters, it will strengthen the medical and scientific interest of the cohort DIVAT and will open new perspectives for clinical trials in surgery and work in epidemiology.Networking of urologists and the expansion of the base DIVAT would carry out research in epidemiology and factors that may play a role in the outcome of renal and pancreatic transplantation. It would also help to define good practices. The first study from the proposed network DIVAT-Uro is assessing the impact of vesico-ureteric reflux on the occurrence of urinary tract infections and effects on survival of the transplant in the recipient adult.

Detailed Description

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Conditions

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Kidney Transplantation Pancreas-kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Capture data

Capture data

Intervention Type OTHER

Capture and standardization of data of patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant from data sources will be performed by clinical research associates.The quality of data will be validated by cross annual audits. The statistical analysis will be made on a case by case according to clinical objectives.

Interventions

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Capture data

Capture and standardization of data of patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant from data sources will be performed by clinical research associates.The quality of data will be validated by cross annual audits. The statistical analysis will be made on a case by case according to clinical objectives.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged over 18 years
* Patients received a kidney transplant or a simultaneous pancreas-kidney transplant
* Patients who read the newsletter and signed the consent form on the computerization of data

Exclusion Criteria

* Patients aged under 18 years
* Patients who did not sign the consent form
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georges KARAM, Profesor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Lionel BADET, Profesor

Role: STUDY_CHAIR

Hospices Civils de Lyon

François IBORRA, Doctor

Role: STUDY_CHAIR

CHU de Montpellier

Jacques HUBERT, Profesor

Role: STUDY_CHAIR

Central Hospital, Nancy, France

Arnaud MEJEAN, Profesor

Role: STUDY_CHAIR

Hôpital Necker - AP-HP

Pascal RISCHMANN, Profesor

Role: STUDY_CHAIR

University Hospital, Toulouse

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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BRD/09/11-E

Identifier Type: -

Identifier Source: org_study_id

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