Protocol DIVAT-Uro

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Nantes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01280708
First received: January 19, 2011
Last updated: September 6, 2011
Last verified: September 2011

January 19, 2011
September 6, 2011
January 2010
January 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01280708 on ClinicalTrials.gov Archive Site
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Protocol DIVAT-Uro
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

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant.

  • Kidney Transplantation
  • Pancreas-kidney Transplantation
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.
Capture data
Intervention: Other: Capture data
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Georges KARAM, Profesor 02 40 08 39 10
France
 
NCT01280708
09/11-E
Yes
Pr Georges KARAM, Nantes University Hospital
Nantes University Hospital
Not Provided
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
Nantes University Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP