Despite worldwide enthusiasm for endoscopic surgery, this new technology is now on the top of McKinlay's “product life circle
curve.” Critical questions are being asked about its benefits and burdens, but the concepts applied and the methodologies
used for technology assessment are in a similar position as endoscopic surgery and need a critical evaluation. (1) There are
incorrect and outdated concepts for the scientific basis of surgery (surgical theory) including the basic sciences involved;
biomedicine still dominates, but assessment of outcome after operations is no longer possible without clinical epidemiology
and social psychology. (2) Based on an outdated scientific theory for surgery, an outdated concept of disease is still propagated.
It is denoted as mechanical and is based solely on biomedicine. Human subjects are reduced to biologic machines, and outcomes
measurement excludes most dimensions of functioning and well-being. To achieve a valid result for outcome measures, a hermeneutic
approach must be combined with the mechanical approach. (3) Based on an outdated model of disease, the outcomes used in endoscopic
surgery rely too much on traditional measures, such as mortality rate, complication rate, hospital stay, and especially an
endless list of biochemical mediators. Their alterations during the perioperative period have not yet been shown to be related
to clinical or hermeneutic outcomes. A new method of assessment for clinical trials in endoscopic surgery and for other surgical
problems is outlined, such as for surgical infections and for surgical oncology. It includes an index of recovery and objective
health status assessed by the doctor, a quality-of-life self-report by the patient, and the true endpoint concept as a critical
weighting of both types of outcome by patients and doctors.