目的:2012年首次报道了良性妇科经阴道自然腔道内镜手术(vNOTES)。在全球范围内,执行此类手术的外科医生数量呈指数级增长,但由于该技术的新近性,没有官方指导以确保安全将其应用于妇科实践。这项研究的目的是报告一项基于国际共识的声明,以帮助指导将vNOTES应用于临床实践的基础。
方法:基于共识的声明是由39名国际专家使用德尔菲方法连续三轮进行的。专家将共识预先定义为80%或更多的协议。共识寻求与vNOTES有关的八个关键概念,包括患者选择,围手术期管理,外科技术,仪器,解剖学,培训,登记和试验以及外科技术的定义。还寻求专家麻醉师和泌尿外科医师的建议,以就vNOTES的实施提供更广阔的视野。
结果:邀请了59名国际外科医生参加,39名(66%)同意参加至少20例VNOTES手术。他们来自5大洲的13个国家(欧洲,北美,南美洲,澳大利亚和亚洲)。所有三轮比赛的参与率均为100%。总的来说,56个问题中的50个(89%)达成共识,其余6个问题未就患者选择领域达成共识.
结论:这里介绍了基于vNOTES的国际专家声明,以根据早期采用者的经验来帮助指导vNOTES的采用。就这一协商一致声明的大部分内容达成了共识。鉴于这种技术的新近出现,直到高级证据可用,该声明为妇科实践安全实施vNOTES提供了适当的指导。
OBJECTIVE: The first ever report of vaginal natural orifice transluminal endoscopic surgery (vNOTES) for benign gynaecological was reported in 2012. There has been an exponential uptake of the number of surgeons performing such procedures worldwide with no official guidance to ensure the safe implementation of this technique into gynaecological practice due its recency. The objective of this study is to report an international consensus-based statement to help guide a basis for adopting
vNOTES into clinical practice.
METHODS: The consensus-based statement was developed amongst 39 international experts using the Delphi methodology over three successive rounds. Consensus was pre-defined as an agreement of 80% or more by the experts.
Consensus sought over eight key concepts pertaining to
vNOTES including patient selection, perioperative management, surgical technique, instruments, anatomy, training, registries and trials and definition of the surgical technique. Recommendations from an expert anaesthetist and urogynaecologist were also sought to give a broader perspective with respect to the implementation of vNOTES.
RESULTS: Fifty nine international surgeons were invited to participate and 39 (66%) agreed to participate based on being involved in a minimum of 20 vNOTES procedures. They were from 13 countries across 5 continents (Europe, North America, South America, Australia and Asia). Participation was 100% on all three rounds. Overall,
consensus was reached in 50 of the 56 questions (89%) with the remaining 6 questions where
consensus was not reached pertaining to the domain of patient selection.
CONCLUSIONS: An international expert based vNOTES statement is presented here to help guide adoption of
vNOTES based on the experience of early adopters.
Consensus was achieved on most components of this
consensus statement. Given the recency of this technique, until high-level evidence becomes available, this statement provides an appropriate guidance to the safe implementation of vNOTES into gynaecological practice.