First step: the idea.
It is a fact that without ideas there is nothing. Without ideas and without innovations there is nothing to test. An interesting, often asked question is: How are ideas, innovations born? It is surely correct that people giving birth to ideas have special characteristics. These creative people are different but still have many, maybe essential, characteristics in common. They are open-minded. Abnormality is interesting for them. They are highly emotional, passionate. They are intelligent and naive at the same time. They are often like children but they also are determined and enjoy their lives. It is a fact that an idea, once born, does not always attain fruition; place, time, social environment, and society have to fit. The domain has to be prepared for it. The true pioneer is the one who has seen the beginning to a certain degree but also brings the new idea to the public, places it on the agenda, accompanies it with positive skepticism, and most of all carries it over the "finishing line." Giving birth to an idea is an important step. Testing the idea regarding its effectivity is a necessity. Since Decartes, in our Western way of thinking, we have a systematic methodic procedure. The idea is expressed in a hypothesis. Here the hypothesis is: "Endoscopic surgery supplies more comfort and means less trauma at the same or greater safety." This is the idea, the dream, the hypothesis. In concrete terms it means less pestering, less pain, less fatigue, and in general a quicker return to daily life during the pre- and postoperative course. Less trauma means less stress response of the body; these are the true endpoints. In the long run, endoscopic surgery means-this being the unproved prerequisite-physical integrity, less immunosuppression, and last but not least consideration of the abdominal wall (in concrete terms, fewer incisional hernias). Thus the relevant endpoints have been formulated by the concrete terms of the hypothesis. This makes clear that comfort relates to-and this is for the first time-"soft" data. This is the true revolution. For me this is a true change of paradigm. Here a few important problems become evident. In the first place, a solution must be found-with the intention of reality and coolness-for the problem of comparing "soft" and "hard" data. With this problem it must be clear that subjective endpoints strongly depend on social and cultural circumstances and are probably influenced more by these factors than by the endoscopic surgery itself. The placebo effect must also be considered. Up to 50% of the subjective endpoints are due to the placebo effect, especially with surgery. For example, pain and return to work depend heavily on socioeconomic aspects and the placebo effect. In summary, the first step is the idea; the second step is testing the idea for effectiveness. Endoscopic surgery as a patient-friendly treatment is the idea, the hypothesis. This hypothesis must be tested according to our present standard of methodology. In addition to the "conventional" endpoints (negative events), the comfort of the patient is the true endpoint of patient-friendly surgery-endoscopic surgery.
2nd Department of Surgery, University of Cologne, Surgical Clinic Cologne-Merheim, Ostmerheimerstrasse 200, 51109 Cologne, Germany.
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D004059:Diffusion of Innovation; D019723:Endoscopes / Q000266:history; D004724:Endoscopy / Q000266:history*; D049673:History, 20th Century; D006801:Humans; D019060:Minimally Invasive Surgical Procedures / Q000266:history