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Protocol DIVAT-Uro

NCT01280708 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1616

Last updated 2021-09-17

No results posted yet for this study

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.

Conditions

  • Kidney Transplantation
  • Pancreas-kidney Transplantation

Interventions

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.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Georges KARAM, Profesor · Nantes University Hospital

  • Lionel BADET, Profesor · Hospices Civils de Lyon

  • François IBORRA, Doctor · CHU de Montpellier

  • Jacques HUBERT, Profesor · Central Hospital, Nancy, France

  • Arnaud MEJEAN, Profesor · Hôpital Necker - AP-HP

  • Pascal RISCHMANN, Profesor · University Hospital, Toulouse

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-02
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01280708 on ClinicalTrials.gov