Literature DB >> 19402251

Re: JSLS(2008)12:295-298 Natural orifice surgery: Transdouglas surgery-a new concept.

Douglas E Ott, Jay A Redan.   

Abstract

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Year:  2009        PMID: 19402251      PMCID: PMC3015917     

Source DB:  PubMed          Journal:  JSLS        ISSN: 1086-8089            Impact factor:   2.172


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We read with interest the article Natural Orifice Surgery: Transdouglas Surgery–a New Concept by Stark M and Benhidjeb T [JSLS(2008)12:295-298]. The article raises questions that must be answered. The designation of the acronym NOS (Natural Orifice Surgery) does not negate the previous use of a natural orifice for endoscopic surgery. Transdouglas luminal endoscopic surgery through the posterior cul-de-sac (pouch of Douglas) is not a “new concept,” making the title misleading. This may seem to be an issue of semantics, but it diminishes the accomplishments of those who have done and reported this type of surgery for over 100 years, as noted in Table 2. Words have meaning, accuracy is important, and calling something new when it isn't is factually incorrect. Renaming established procedures does not make them new. Culdoscopy has a long gynecologic tradition and has been recently used for diagnostic and therapeutic purposes in fertiloscopy, a direct vision procedure.[1] The instrument described as TED (Transdouglas Endoscopic Device) the article says is “being developed.” This is a preliminary report about an instrument in the process of development with no animal or human reports, only “simulated” ones. Simulation is no substitute for clinical proof. This leap of faith from simulation to clinical use is without basis. Conclusions formulated by gedanken are not always as they seem, and their strong beliefs must be supported by data beyond a physical description of the device. The article claims that the shape of the “head” would not “lead to any injury.” How do they know this? What's the proof? Whatever benefits the authors conjured up are just that-conjectured up-and not valid. The assumption that reduced intraabdominal pressure will result without experimental verification is a false statement. The database of the article is a physical and numerical description of the device and not data about use, safety, or efficacy. Patent applications, European or US, must be “reduced to practice” and able to be reproduced by “one skilled in the art” when they are applied for. The article says TED is not complete, not tested, and still under development saying, “there will be housed in the head,” not there is housed in the head. “Will be” is the future; “there is” represents present existence. The authors say they “have no commercial associations that might pose a conflict of interest in connection with the submitted article, except a patent-pending arrangement for the TED that was assigned by author MS.” Assignment by “an inventor” to someone else or entity is done for commercial development with compensation to the inventor as the authors note for TED's assignment. In fact “manufacturing of the device is in progress.” The integrity of the authors and JSLS are important to preserve and maintain. There is nothing wrong or inappropriate with such arrangements, but they must be disclosed and with straight-forward language, not tortuous exceptions. TED has been previously reported by these authors and not referenced.[2,3] In short, TED is not new, but previously reported and has no clinical data.
  2 in total

Review 1.  [The natural orifice surgery concept. Vision and rationale for a paradigm shift].

Authors:  T Benhidjeb; K Witzel; E Bärlehner; M Stark
Journal:  Chirurg       Date:  2007-06       Impact factor: 0.955

2.  Place of transvaginal fertiloscopy in the management of tubal factor disease.

Authors:  A Watrelot
Journal:  Reprod Biomed Online       Date:  2007-10       Impact factor: 3.828

  2 in total

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