Guarner V

Language: Spanish
References: 19
Page: 445-448
PDF size: 40.90 Kb.

ABSTRACT

This article analyses three terms that are often cited in the current surgical literature: improvisation, innovation and surgical research. Each one has a totally different definition yet in our daily practice terms are often confused and even used as synonyms. A wide variety of novel technical procedures are developed and sometimes published without being first subjected to rigorous peer review. These results sometimes are a by-product of improvisation. Often, these new techniques have undoubtedly contributed to the progress of surgery but in other cases, measured in the immediate or long terms, side effects have become unpredictable and have caused serious harm. In this article, I carried out a review of the literature with the aim of proposing a more rigorous approach for the publication of research results in the changing field of surgery.

REFERENCES

1. Guarner V. Trente ans d’expérience avec la fundoplastie postérieure dans le traitement du reflux gastro-oesophagien (analyse de 1499 cas). Chirurgie 1997;122:443-449.

2. Rydygier L. Extirpation des carcionomatösen pylorus. Tod nach zwölf Studen. Deutsche Ztschr Chir 1880;14:252-255.

3. Pean JE. De l´ablation des tumeurs de I´estomac par la gastrectomie. Gaz des Hopitaux 1879;52:453-455.

4. Billroth TH. Themes in clinical surgery. Traducida por Dent Ct. London 1881.

5. Rutan RI, Deitch EA, Waymack JP. Academic surgeons knowledge and Food and Drug Administration Regulation for clinical trials. Arch Surg 1997;132:94-98.

6. Reitsma AM, Moreno JD. Ethical regulations for innovative surgery: The last frontier? J Am Coll Surg 2002;2002194:792-801.

7. Moreno JD. Protectionism in research involving human subjects. National Bioethics Advisory Commission. Ethical and policy issues in research involving human participants. Vol II (Commissioned papers). Washington DC; 2001.

8. Spodick DH. Numerators without denominators. There is no FDA for the surgeon. JAMA 1975;232:35-36.

9. Secretaría de Salud. Reglamento de la Ley General de Salud en Materia de Investigación. México: Diario Oficial de la Federación, 6 de enero de 1987.

10. Jones MA. A miracle and yet. New York Times. July 15, 2001.

11. Reitsma A. Regulating innovative surgery: The last frontier. US: University of Virginia Graduate School of Arts and Science; 2004.

12. Ward CM. Surgical research, experimentation and innovation. Br J Plast Surg 1994;47:90-94.

13. McKneally MF, Daar AS. Introducing new technologies: Protecting subjects of surgical innovation and research. World J Surg 2003;27:930-935.

14. Beecher HK. Surgery as a placebo, a quantitative study of bias. JAMA 1961;176:1102-1107.

15. Peltier LF, Bradley JA. L´étoile du nord. An account of Owen Harding Wangensteen (1898-1981). Aust, Chicago: American College of Surgeons; 1994.

16. Pendenrgast MK. Deputy Commission for the Study in Medicine and Biomedical and Behavioral Research. Washington DC: US Department of Health and Human Services; 1997.

17. Reitsma A. Surgical research, in elusive entity. Am J Bioeth 2003;3:49-50.

18. Reitsma A, Moreno J. Ethics of innovative surgery: US surgeon’s definitions, knowledge and attitude. J Am Coll Surg 2000;1:103-110.

19. Declaració de Hèlsinki (2000). Asociació Mèdica Mundial. Principis ètics per a la recerca mèdica amb subjectes humans. Bioètica & Debat 2001;6:1-16.