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Protocol DIVAT-Uro

Sponsor
Nantes University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01280708
Collaborator
(none)
1,616
Enrollment
1
Location
24
Actual Duration (Months)
67.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Capture data

Study Design

Study Type:
Observational
Actual Enrollment :
1616 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Establishment of a National Thematic Network in Urology for the Extension of the Cohort DIVAT (Données Informatisées et Validées en Transplantation) in Surgical Parameters of Renal and Pancreatic Transplant Patients : An Innovative Tool for the Promotion of Epidemiological Studies, Identification of Risk Factors and Good Practices in the Domain of Transplant Surgery
Actual Study Start Date :
Jan 2, 2012
Actual Primary Completion Date :
Dec 31, 2013
Actual Study Completion Date :
Dec 31, 2013

Arms and Interventions

Arm Intervention/Treatment
Capture data

Other: 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.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nantes University Hospital Nantes France 44093

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    • Principal Investigator: Georges KARAM, Profesor, Nantes University Hospital
    • Study Chair: Lionel BADET, Profesor, CHU de Lyon
    • Study Chair: François IBORRA, Doctor, CHU de Montpellier
    • Study Chair: Jacques HUBERT, Profesor, CHU de Nancy
    • Study Chair: Arnaud MEJEAN, Profesor, Hôpital Necker - AP-HP
    • Study Chair: Pascal RISCHMANN, Profesor, University Hospital, Toulouse

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT01280708
    Other Study ID Numbers:
    • BRD/09/11-E
    First Posted:
    Jan 21, 2011
    Last Update Posted:
    Sep 17, 2021
    Last Verified:
    Sep 1, 2011
    Keywords provided by Nantes University Hospital
    Urology
    Nephrology
    Renal and pancreas transplantation
    Data base
    Epidemiology

    Study Results

    No Results Posted as of Sep 17, 2021