Delayed assessment and eager adoption of laparoscopic cholecystectomy: implications for developing surgical technologies

Abstract

Despite the prevailing emphasis in the medical literature on establishing evidence, many changes in the practice of surgery have not been achieved using proper evidence-based assessment. This paper examines the adoption of laparoscopic cholecystectomy (LC) into regular use for the treatment of cholecystitis and the process of its acceptance, focusing on the limited role of technology assessment in its appraisal. A review of the published medical literature concerning LC was performed. Approximately 3000 studies of LC have been conducted since 1985, and there have been nearly 8500 publications to date. As LC was adopted enthusiastically into practice, the results of outcome studies generally showed that it compared favorably with the traditional, open cholecystectomy with regard to mortality, complications, and length of hospital stay. However, despite the rapid general agreement on surgical technique, efficacy, and appropriateness, there remained lingering doubts about safety, outcomes, and cost of the procedure that suggested that essential research questions were ignored even as the procedure became standard. Using LC as a case study, there are important lessons to be learned about the need for important guidelines for surgical innovation and the adoption of minimally invasive surgical techniques into current clinical and surgical practice. We highlight one recent example, natural orifice transluminal endoscopic surgery and how necessary it is to properly evaluate this new technology before it is accepted as a safe and effective surgical option.

Figure 1

Evolution of technology, laparoscopic cholecystectomy and natural orifice transluminal endoscopic surgery. A: A timeline of the percentage of the total number of articles dealing with laparoscopic cholecystectomy’s safety reveals the failure of the literature to satisfactorily answer essential safety issues early in the technology-assessment process; B: An evaluation of the study designs present in the natural orifice transluminal endoscopic surgery (NOTES) literature reveals that the vast majority of studies are technological reports, experimental studies in animal models or simulators, or editorials/commentaries. To date, there have been no clinical studies other than a handful of case reports/series; C: The present literature on NOTES is dedicated primarily to experimental procedures, instrumentation, and theoretical discussion such as advantages/disadvantages or indications/contraindications. Few articles have been devoted to safety or outcome studies, and no articles have compared NOTES procedures to their traditional open or laparoscopic counterparts.