The development and implementation of a computerized database for clinical research in minimal access surgery. An international pilot study.

Abstract

The measurement of outcomes after minimal access surgery (MAS) relies on the maintenance of an accurate, prospective clinical database. The development of a system for data management often proves to be challenging, expensive, and extremely time-consuming. We developed a computerized relational database for MAS using Microsoft Access 97 to reside on a hospital server, taking advantage of existing network connections, security, and backup systems. The design of the database includes a point-and-click approach with dropdown boxes for diagnoses, procedures, and complications (limited free-text entry). A fundamental feature of this database allows surgeons and surgical trainees to record clinical information at the point and time of data acquisition. A "beta version" or fully functional draft of the database was presented to a group of surgeons from a variety of specialties (n = 8), and a structured interview based on a questionnaire was used to elicit the surgeon's evaluations of the database. Using the information from the interviews, the database was extensively revised and restructured. We have developed a relational database that reflects the needs of surgeons interested in clinical research. This database may serve as a template for other centers. It can be expanded to adopt new procedures or modified for other surgical specialties.