Surgical Innovation and the Multiple Meanings of Randomized Controlled Trials: The First RCT on Minimally Invasive Cholecystectomy (1980-2000).

This article uses the case of the first randomized controlled trial (RCT) evaluating laparoscopic cholecystectomy to investigate the introduction of minimally invasive surgery in the 1990s and explore the meaning of RCTs within the context of the introduction of a new surgical technology. It thus brings together the history of the use of laparoscopic cholecystectomy to remove the gallbladder, and the history of the RCT, shedding light on particular aspects of both. We first situate the RCT in the context of the history of the various treatment options for gallstones, or cholelithiasis, then characterize the specific situation of the rapid, patient-driven spread of laparoscopic cholecystectomy, and in a next step describe how the local context of laparoscopic cholecystectomy as a new technology made it possible and desirable to conduct an RCT, despite numerous obstacles. This article then shows that in order to capture and understand the rationale of an RCT it is worth it to explore the various levels and dimensions of its context, demonstrating how even the RCT as an ostensibly universal tool draws its meaning from its contexts and that this meaning goes beyond the simple determination of efficiency and safety, including, maybe most importantly, the control and management of new technologies.