Protocol DIVAT-Uro

This study is currently recruiting participants.

Verified September 2011 by Nantes University Hospital

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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 19, 2011

Last Updated Date

September 6, 2011

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01280708 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Protocol DIVAT-Uro

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Kidney Transplantation
Pancreas-kidney Transplantation

Intervention ^ICMJE

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.

Study Group/Cohort (s)

Capture data

Intervention: Other: Capture data

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2000

Estimated Completion Date

January 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Georges KARAM, Profesor

02 40 08 39 10

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01280708

Other Study ID Numbers ^ICMJE

09/11-E

Has Data Monitoring Committee

Yes

Responsible Party

Pr Georges KARAM, Nantes University Hospital

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Nantes University Hospital

Verification Date

September 2011

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

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