“…Though the definition of what should constitute a new procedure itself can be arbitrary [14,15] and has been one of the biggest stumbling blocks in developing a clear framework for surgical innovation, generally if an operation is different enough from the existing alternatives to need a new name, it could safely be categorized as a new procedure. At the same time, one recognizes that major alterations in even existing procedures itself should probably go through a process of closer monitoring.…”
Background There is currently no consensus on the criteria for inclusion of new bariatric procedures into routine clinical practice. This study canvasses bariatric surgeons in an attempt to define these criteria. Methods Bariatric Surgeons from around the world were invited to participate in a questionnaire-based survey on SurveyMonkey ®. Conclusion Evaluation of a new bariatric procedure in at least 5 adequately supervised clinical studies (four of which must be randomized comparisons with one of the existing alternatives) reporting at least 5 years results on a minimum of 500 patients would satisfy majority of bariatric surgeons for the inclusion of a new bariatric procedure into clinical practice. The findings of this survey are simply aimed at starting a discussion on this topic and cannot be used to influence the ground reality until an international consensus can be reached amongst experts.
“…Though the definition of what should constitute a new procedure itself can be arbitrary [14,15] and has been one of the biggest stumbling blocks in developing a clear framework for surgical innovation, generally if an operation is different enough from the existing alternatives to need a new name, it could safely be categorized as a new procedure. At the same time, one recognizes that major alterations in even existing procedures itself should probably go through a process of closer monitoring.…”
Background There is currently no consensus on the criteria for inclusion of new bariatric procedures into routine clinical practice. This study canvasses bariatric surgeons in an attempt to define these criteria. Methods Bariatric Surgeons from around the world were invited to participate in a questionnaire-based survey on SurveyMonkey ®. Conclusion Evaluation of a new bariatric procedure in at least 5 adequately supervised clinical studies (four of which must be randomized comparisons with one of the existing alternatives) reporting at least 5 years results on a minimum of 500 patients would satisfy majority of bariatric surgeons for the inclusion of a new bariatric procedure into clinical practice. The findings of this survey are simply aimed at starting a discussion on this topic and cannot be used to influence the ground reality until an international consensus can be reached amongst experts.
“…As an orthopedic surgeon, David's father often had a clear and direct intervention that could significantly improve patient outcomes [8]. Conversely, in the field of Oncology, the patient treatment plan is often complex and multifaceted [9].…”
“…Therefore, a useful definition of innovative surgery for our purposes is ''a novel procedure, a significant modification of a standard technique, a new application of or new indication for an established technique or an alternative combination of an established technique with another therapeutic modality that was developed and tested for the first time'' [12].…”
Section: Distinction Between Innovation and Modification/''me-too'' Tmentioning
Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.
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