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首页> 外文期刊>Surgical Endoscopy >NOTES transvaginal cholecystectomy: preliminary clinical application.
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NOTES transvaginal cholecystectomy: preliminary clinical application.

机译：注意事项经阴道胆囊切除术：初步临床应用。

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BACKGROUND: Natural orifice translumenal endoscopic surgery (NOTES) is an emerging concept in the recent literature that could lead to potential benefits in clinical applications. Restricted to animal experiments, however, human procedures have not yet been published. Because of the technical and ethical challenges involved in perforation and closure of a healthy organ-as is also seen in operating via the transgastric route-and because of the lack of understanding of the physiopathology and infection risk with these approaches, they have not been applied in the clinical setting. Thus the present study, based on previous animal experiments, describes preliminary clinical application in four cases of transvaginal NOTES cholecystectomy, and discusses safety, feasibility, and potential benefits of the method. METHODS: Preliminary acute and survival animal experiments developed by the NOTES Research Group at our institution solved such technical problems for transvaginal NOTES as spatial orientation, insufflation, and instrumentation, making possible the introduction of NOTES as a clinical application. The trials were approved by ethics committee of our institution, and informed consent was obtained from all patients. Since 13 March 2007, four female patients with elective surgical indication for cholecystectomy have undergone transvaginal NOTES cholecystectomy. All intraoperative and postoperative parameters were documented. Vaginal access was achieved under direct vision with conventional instruments, and a 2-channel colonoscope was inserted into the abdominal cavity. After endoscopic insufflation to achieve pneumoperitoneum with CO(2), instruments were inserted through and alongside a colonoscope, allowing successful NOTES cholecystectomy in all patients, with vaginal extraction of the gallbladder. The vaginal wound was closed by direct vision using conventional instruments. RESULTS: The procedure was successful in all patients, with operative time of 45-115 min. Patients experienced low need for postoperative analgesia. Free oral intake was permitted 2 h after the procedure. There were no postoperative complications, and patients were discharged, according to the study protocol, 48 h after the procedure. CONCLUSIONS: Preliminary results showed the feasibility and safety of the transvaginal NOTES method in this small initial study population. The technique, developed in our institution, and not transgastric NOTES, may be the preferred approach to serve as the basis for clinical studies.
机译：背景：自然孔腔内镜手术（NOTES）是最近文献中的一个新兴概念，可能在临床应用中带来潜在的好处。但是，仅限于动物实验，尚未公开人类程序。由于健康器官的穿孔和闭合所涉及的技术和伦理挑战（如通过经胃途径进行操作时所见）以及由于缺乏对这些方法的生理病理学和感染风险的了解，因此尚未应用它们在临床环境中。因此，本研究基于先前的动物实验，描述了在经阴道NOTES胆囊切除术的4例病例中的初步临床应用，并讨论了该方法的安全性，可行性和潜在益处。方法：由本机构的NOTES研究小组进行的初步急性和存活动物实验解决了经阴道NOTES的空间定位，吹入和仪器化等技术问题，从而使NOTES作为临床应用成为可能。试验已获得本机构伦理委员会的批准，并获得所有患者的知情同意。自2007年3月13日以来，有4例接受手术切除的女性胆囊切除术患者接受了经阴道NOTES胆囊切除术。记录所有术中和术后参数。使用常规仪器在直视下可实现阴道进入，并将2通道结肠镜插入腹腔。内窥镜通气以CO（2）达到气腹后，将器械插入并通过结肠镜检查，并在所有患者中成功进行NOTES胆囊切除术，并从阴道胆囊中取出。使用常规仪器通过直视闭合阴道伤口。结果：该手术对所有患者均成功，手术时间为45-115分钟。病人术后镇痛的需求较低。手术后2小时允许口服。根据研究方案，手术后48小时无术后并发症，患者已出院。结论：初步结果表明经阴道NOTES方法在这个小的初始研究人群中的可行性和安全性。该技术是在我们机构中开发的，而不是经胃NOTES，可能是临床研究的首选方法。

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