Study methods in evidence-based surgery: methodological impediments and suggested approaches for the creation and transfer of knowledge in surgery.

Background: Since its introduction more than 20 years ago, evidence-based medicine has become an important principle in the daily routine of clinicians around the globe. Nevertheless, many surgical interventions are still not based on high-quality evidence from clinical trials. This is partially due to the fact that surgical trials pose some specific obstacles, which have to be overcome during the planning and conduct of such a trial.

Objective: In this study, we will highlight specific challenges and discuss explicit obstacles of surgical clinical research. Moreover, potential solutions will be substantiated by the experience of the Study Centre of the German Surgical Society (SDGC) in surgical clinical research.

Conclusions: Surgical researchers should be equipped with a basic knowledge of research methodology to be able to overcome the common impediments posed by surgical trials. Collaborations between surgeons and methodologists as well as trial networks have proven to be useful in accomplishing high-quality surgical research in various randomized controlled trials. By maintaining and refining this work and with sufficient and prompt translation of investigational knowledge into daily practice, the treatment of surgical patients should result in an improved outcome in the future.