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Protocol DIVAT-Uro

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280708
Recruitment Status : Unknown
Verified September 2011 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : January 21, 2011
Last Update Posted : September 7, 2011
Information provided by:
Nantes University Hospital

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
Kidney Transplantation Pancreas-kidney Transplantation Other: Capture data

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Study Type : Observational
Estimated Enrollment : 2000 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
Study Start Date : January 2010
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Group/Cohort 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01280708

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Contact: Georges KARAM, Profesor 02 40 08 39 10

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Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Georges KARAM, Profesor    02 40 08 39 10      
Principal Investigator: Georges KARAM, Profesor         
Sponsors and Collaborators
Nantes University Hospital
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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
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Responsible Party: Pr Georges KARAM, Nantes University Hospital Identifier: NCT01280708    
Other Study ID Numbers: 09/11-E
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011
Keywords provided by Nantes University Hospital:
Renal and pancreas transplantation
Data base