Transition from Laboratory to Clinical Practice in NOTES: Role of NOSCAR

Hawes, Robert H.

doi:10.1016/j.giec.2008.01.003

Cited by 10 publications

(3 citation statements)

References 19 publications

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“…The Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR), a joint initiative supported by the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), was set up in July 2005 to oversee and guide the development and introduction of NOTES into clinical practice [4]. It is anticipated that in the near future, NOSCAR will launch a registry of human NOTES procedures to which members can add.…”

Section: Introductionmentioning

confidence: 99%

Natural orifice translumenal endoscopic surgery: critical appraisal of applications in clinical practice

et al. 2009

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Although initial human results seem encouraging, it is important that this research be conducted in a way that minimizes bad publicity and describes both favorable and adverse outcomes. Robust trials must be conducted at established centers with appropriate experience and institutional board ethical review to allow safe introduction of this novel technique, with adequate and expedient reporting of serious adverse events. The limitations of the current tools and methods are discussed, and suggestions are made for further improvements in the technology to facilitate NOTES operations.

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Section: Introductionmentioning

confidence: 99%

Natural orifice translumenal endoscopic surgery: critical appraisal of applications in clinical practice

et al. 2009

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“…In fact, a recent large meta-analysis of the NOTES literature [4] focusing on various surgical intraabdominal procedures, all ascribable to EA-NOS, concluded that no human studies were found satisfactory for the inclusion criteria, for scarce disposable evidence, minor safety, and efficacy compared to laparotomy and laparoscopy. The recommendation that human procedures should first pass through hybrid NOTES surgery, under strict guidelines, and in apposite controlled registers was later supported, as known, by the revision of NOSCAR ''white paper'' [5]. In fact, a need for a worldwide register, a standardization of the nomenclature, safety data to be used by ethical committees in order to authorize human trials, and implementation of the interface between medical societies, industry, and regulatory offices is no longer discussed.…”

mentioning

confidence: 99%

Endoscopic surgery through single-port incision: time for a trial?

Arezzo

Morino

2011

Surg Endosc

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“…The metaanalysis found that no human studies satisfied the inclusion criteria due to scarce disposable evidence and minor safety and efficacy compared with laparotomic and laparoscopic alternatives. The recommendation for human procedures to pass first through hybrid NOTES surgery under strict guidelines and in apposite controlled registers was supported later by the revision of the natural orifice surgery consortium for assessment and research (NOSCAR) ''white paper'' [4]. In fact, it is undebatable that a need exists for a worldwide register to standardize nomenclature and safety data (useful for authorization of human trials by ethical committees) and to implement the interface between medical societies, industry, and regulatory offices.…”

mentioning

confidence: 99%