The Need for Registries in the Early Scientific Evaluation of Surgical Innovations

As a field, surgery has generated some of the leading innovators in history (1). Advances in immunology and microbiology knowledge and exciting technological developments, e.g. 3-D-imaging, robotic surgery, natural orifice transluminal endoscopic surgery, tissure engineering and 3-D-priting, will maintain the innovation potential in the field of surgery on a high level. Randomized controlled trials (RCT) represent the gold standard for evaluation of the safety and efficacy of surgical interventions. There are several factors that make conduct of RCTs of surgical procedures particularly difficult. Therefore in the past the majority of surgical innovations were accepted on the basis of non-randomized trials (2). That this is actually the case can be demonstrated, in particular, by the reaction to the introduction of laparoscopic cholecystectomy, which was greeted by Sir Alfred Cushieri as the “greatest unaudited procedure in the history of surgery” (3) The first minimally invasive gallbladder-removal procedure was performed by Mühe in Germany in 1985 using a galloscope he himself had designed (4), and the first video-endoscopic cholecystectomy was carried out by Mouret in France in 1987 (3). The first case series was then published by Dubois in 1989 with 63 cases (5), and by Perissat in 1992 with 777 cases (6). By that time, laparoscopic cholecystectomy had already become established in many hospitals worldwide. A problematic issue during that phase of “scientific uncertainty” was the significantly higher rate of common bile duct injuries, especially during the learning curve (7). The first report on a prospective randomized trial comparing laparoscopic with open cholecystectomy were published in 1992, attesting to the benefits of the minimally invasive technique (8). However, the sample size in that first RCT was only 70 patients. It was only in 2006, when the Cochrane Collaboration reviewed in a meta-analysis of 38 RCTs with 2,338 patients, i.e. on average 62 patients per study, that it was possible to issue a scientifically corroborated statement demonstrating that laparoscopic cholecystectomy did not differ from the open technique in terms of mortality, complication rate or operating time, but did result in a shorter hospital stay and quicker convalescence (9). The authors thus concluded that “these results confirm the existing preference for the laparoscopic cholecystectomy over open cholecystectomy”. It thus took 20 years from the initial introduction of video-endoscopic cholecystectomy until scientific proof of the highest level evidence according