The Study Centre of the German Surgical Society--rationale and current status.

Background: The concept of evidence-based medicine was introduced into surgery in the mid-1990s, initially focussing on the integration of best research evidence, surgeons' expertise and patients' value. The lack of relevant external evidence [randomised controlled trials (RCTs), systematic reviews] in favour of surgical procedures has led to the need for a new approach in clinical research.

Design: Development and implementation of the Study Centre of the German Surgical Society (SDGC) in order to design, perform and analyse multicentre randomised controlled trials in surgery.

Results: The German Surgical Society has recently initiated four surgical RCTs within the SDGC in order to improve the national infrastructure for clinical research and its international scientific standing. All surgical trials focus on procedures in various fields (thyroid and parathyroid diseases, pancreatic surgery, abdominal wall closure) and are designed to fit the specific needs of each study (blinding of patients and assessors, ranking of endpoints, patients' perspective). Additionally, in a nationwide survey of 1,274 surgical departments in Germany, 307 replied, of which 237 (19%) were willing to participate in multicentre projects.

Conclusion: Evidence-based medicine has changed surgical practice, leading to an increase in demand for RCTs and requiring a new infrastructure in surgical departments and scientific societies.