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
  Purpose

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 Intervention
Kidney Transplantation
Pancreas-kidney Transplantation
Other: Capture data

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Estimated Enrollment: 2000
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280708

Contacts
Contact: Georges KARAM, Profesor 02 40 08 39 10

Locations
France
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
Investigators
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
  More Information

No publications provided

Responsible Party: Pr Georges KARAM, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01280708     History of Changes
Other Study ID Numbers: 09/11-E
Study First Received: January 19, 2011
Last Updated: September 6, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Nantes University Hospital:
Urology
Nephrology
Renal and pancreas transplantation
Data base
Epidemiology

ClinicalTrials.gov processed this record on August 01, 2014