Development and perspectives of randomized controlled trials in surgery

After introduction of the randomized controlled trial (RCT) into clinical research within the second half of the 20th century, the number of high-quality RCTs comparing surgical techniques has been low, although this trial design has widely been acknowledged to provide the highest available level of evidence. Reasons for the paucity of RCTs dealing with surgical techniques have been attributed to specific challenges of these trials requiring elaborate methodologic considerations, as well as complex organization, raising questions regarding their feasibility. However, unrelenting efforts of certain clinicians who realized surgical trials, even in times of weak infrastructure for clinical research in surgery, have proved that RCTs are feasible, even within daily clinical routine. Furthermore, these trials helped to increase awareness for the need of more surgical RCTs among clinicians and individuals in charge of funding institutions. As a result, a positive development of patient-oriented surgical research has been observed within the last years. The number of surgeons willing to participate in trials is rising. In addition, increased financial support from governmental institutions could be obtained to establish a working infrastructure for surgical research. Nonetheless, there are still issues of surgical RCTs regarding their quality, reporting, and study design. Addressing these aspects is essential for successful continuation of what was initiated with the first surgical RCT more than 40 years ago.