Protocol DIVAT-Uro

NCT01280708 | Terminated DMC

• 1 other identifier: BRD/09/11-E
• Study Type: observational
• Target: 1,616
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation; Pancreas-kidney Transplantation

Keywords

Urology; Nephrology; Renal and pancreas transplantation; Data base; Epidemiology

Study Arms (1)

Capture data

Other: Capture data

Interventions

Capture data OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients aged under 18 years
• Patients who did not sign the consent form

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Study Officials

• Georges KARAM, Profesor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Lionel BADET, Profesor

  Hospices Civils de Lyon

  STUDY CHAIR

• François IBORRA, Doctor

  CHU de Montpellier

  STUDY CHAIR

• Jacques HUBERT, Profesor

  Central Hospital, Nancy, France

  STUDY CHAIR

• Arnaud MEJEAN, Profesor

  Hôpital Necker - AP-HP

  STUDY CHAIR

• Pascal RISCHMANN, Profesor

  University Hospital, Toulouse

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 21, 2011
• Study Start: January 2, 2012
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: September 17, 2021

Record last verified: 2011-09

Locations

FR (1)