Clinical trial NCT01280708: Protocol DIVAT-Uro
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Transplantation
Pancreas-kidney Transplantation
Keywords: Urology
Nephrology
Renal and pancreas transplantation
Data base
Epidemiology
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-01-21
Enrollment: 1616
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant.

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Georges KARAM, Profesor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: Lionel BADET, Profesor
role: STUDY_CHAIR
affiliation: CHU de Montpellier
name: François IBORRA, Doctor
role: STUDY_CHAIR
affiliation: Central Hospital, Nancy, France
name: Jacques HUBERT, Profesor
role: STUDY_CHAIR
affiliation: Hôpital Necker - AP-HP
name: Arnaud MEJEAN, Profesor
role: STUDY_CHAIR
affiliation: University Hospital, Toulouse
name: Pascal RISCHMANN, Profesor
role: STUDY_CHAIR
References: