European Group of Robotic Urology

Internet based clinical trial of robotically assisted laparoscopic prostatectomy

Clinical trial objectives

The goals of the clinical study are the following :

  • clinical study on the practice of robotically assisted laparoscopic prostatectomy for the treatment of localized prostate cancer.

Access to the database

Description of the Internet Database

The Geneva Foundation for Medical Education and Research (GFMER) has developed a web application composed of web oriented interface that is informatically connected to a database. The goal of the web forms and the database is to allow the collection and evaluation of data as it pertains to the study of clinical practices of robotically assisted laparoscopic prostatectomy for the treatment of localized prostate cancer.

The system allows a multi centric administration and management of data, and allows multiple users. An easy access to the collected data has been made possible using the search capabilities of this tool. Statistical analysis is presented both in text form and graphical charts; The statistics are updated in real-time so that they accurately reflect the latest data that has been collected.

The database itself is scurried in terms of user access, authentication level, auditing / logging of processes and actions, and preservation of anonymity where required. Authorized users are able see data that has been entered into the system and to export that data in a form that is readable by Microsoft Excel or other statistical analysis software. The core database application is coordinated by GFMER in collaboration with recognized international experts.

Some of the detailed aspects of the data-base implementation are the following :

  • System software is built in the scripting language PHP.

  • The underlying database server infrastructure is open source MySQL relational database.

  • The software platform for the web server is the openwork Apache server software running on the University Hospital of Geneva's hardware platforms.

  • Weekly backup of the data occurs on the root site and on the secondary site.

  • Standard Operating Procedures (SOP) documents, System software description, and revision control of all software and documentation is managed using the SVS software revision system platform.

  • All data in the software is retained, including all modifications of individual data elements collected for the study as it evolves over time (for auditing purposes).

  • Where possible, the data collection forms are officially sanctioned 'validated' forms.

  • The web application may be accessed using a variety of web browsers including Internet Explorer, Netscape Navigator, and Firefox.

  • Access to the database is available through a login portal, to users with valid accounts. New accounts may be provided on request.