17 research outputs found

    Getting clearer about surgical innovation : a new definition and a new tool to support responsible practice

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    OBJECTIVES: This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the responsible introduction of surgical innovations. BACKGROUND: Frameworks developed for the safer introduction of surgical innovations rely upon identifying cases of innovation; oversight cannot occur unless innovations are identified. However, there is no consensus among surgeons about which interventions they consider innovative; existing definitions are vague and impractical. METHODS: Using conceptual analysis, this article synthesizes findings from relevant literature, and from qualitative research with surgeons, to develop an original definition of surgical innovation and a tool for prospectively identifying planned surgical innovations. The tool has been developed in light of feedback from health care professionals, surgeons, and policy makers. RESULTS: This definition of innovation distinguishes between variations, introduction of established interventions, and innovations in surgical techniques or use of devices. It can be applied easily and consistently, is sensitive to the key features of innovation (newness and degree of change), is prospective, and focuses on features relevant to safety and evaluation. The accompanying tool is deliberately broad so that appropriate supports may, if necessary, be provided each time that a surgeon does something "new". CONCLUSIONS: The definition presented in this article overcomes a number of practical challenges. The definition and tool will be of value in supporting responsible surgical innovation, in particular, through the prospective identification of planned innovations.6 page(s

    Identifying surgical innovation : a qualitative study of surgeons' views

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    OBJECTIVE:: This study explores how surgeons define innovation, critically examines and evaluates these views, and uses the findings to develop practical criteria for identifying surgical innovation for ethical and regulatory purposes. BACKGROUND:: Surgical innovation is crucial for progress in surgery, but can be harmful to patients and difficult to identify and therefore support appropriately. Current attempts to define surgical innovation lack precision, and do not give enough guidance to identify innovations in practice. This study is the first to give an account of surgeons' own views about defining innovation. METHODS:: This qualitative study involved interviews with 18 Australian surgeons. Participants provided examples of innovation and distinguished innovation from variations in practice and from research. Data were collected using audio-recorded semistructured interviews. The data were coded using a template and analyzed to develop a thematic account of innovative surgery in practice. RESULTS:: There was no uniform view about innovation, but participants identified 5 features of surgical innovation that distinguish it from variations: newness or novelty; degree of change; level of risk; impact; and requiring formal processes. There was no agreement on the distinction between innovation and research. CONCLUSIONS:: Drawing on surgeons' own views is important for the development of a practical definition of surgical innovation. We have used a critical analysis of surgeons' own views as the basis for defining the core features of innovation. A precise definition of innovation will assist surgeons to identify and manage innovation and thereby enhance patient safety.6 page(s

    Long-term functional outcomes after laparoscopic and open rectopexy for the treatment of rectal prolapse

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    Purpose: Laparoscopic rectopexy to treat full-thickness rectal prolapse has proven short-term benefits, but there is little long-term follow-up and functional outcome data available. Methods: Patients who had abdominal surgery for prolapse during a ten-year period were identified and interviewed to ascertain details of prolapse recurrence, constipation, incontinence, cosmesis, and satisfaction. Additional details on recurrences that required surgery and mortality were obtained from chart review and the State Death Registry. Results: Of 321 prolapse operations, laparoscopic rectopexy was performed in 126 patients, open rectopexy in 46, and resection rectopexy in 21 patients. At a median follow-up of five years after laparoscopic rectopexy, there were five (4 percent) confirmed full-thickness recurrences that required surgery. Actuarial recurrence rates of laparoscopic rectopexy were 6.9 percent at five years (95 percent confidence interval, 0.1–13.8 percent) and 10.8 percent at ten years (95 percent confidence interval, 0.9–20.1 percent). Seven patients underwent rubber band ligation for mucosal prolapse and seven required other surgical procedures. There was one recurrence after open rectopexy (2.4 percent) and one after resection rectopexy (4.7 percent), and there was no significant difference between groups. Overall constipation scores were not increased after laparoscopic rectopexy, with no significant difference to open rectopexy or resection rectopexy. Conclusions: This study has demonstrated that laparoscopic rectopexy has reliable long-term results for treating rectal prolapse, including low recurrence rates and no overall change in functional outcomes.8 page(s
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