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A Prospective Multicenter Registry of Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas

机译:子宫息肉和子宫肌瘤的宫腔镜下拆开术患者的前瞻性多中心注册表。

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摘要

>Background: Hysteroscopic morcellation removes uterine pathology under direct visualization with continuous real-time tissue fragment removal. >Objective: The aim of this study was to explore the feasibility of hysteroscopic morcellation across a diverse set of facilities, including both surgical and office-based settings. >Design: This was a prospective, single-arm, multicenter registry development (Canadian Task Force classification II-3). >Materials and Methods: Thirty-four U.S. obstetrics and gynecology facilities enrolled subjects into the registry. Inclusion criteria were women ages 18–65 with indications for hysteroscopic myomectomy and/or polypectomy who were treated with the MyoSure® Hysteroscopic Tissue Removal System (Hologic Inc., Marlborough, MA). Intrauterine lesion type/size and removal parameters, adverse events (AEs), and physician satisfaction ratings were recorded. >Results: A total of 559 pathologies (187 fibroids; 372 polyps) were removed from 278 registered subjects (mean age: 43.9 ± 9.0 years), with 250 procedures (89.9%) performed in an ambulatory surgery center or hospital outpatient setting and 28 (10.1%) in a gynecologic office setting. Most patients (n = 206, 74.1%) were treated for abnormal uterine bleeding, and 42 (15.1%) were treated for infertility. Mean fibroid diameter was 2.2 ± 1.2 cm. Mean polyp diameter was 1.3 ± 1.0 cm. Overall mean percentage of pathology removed was 95.4% (polyps 99.3%, fibroids 86.8%). Five AEs included four incidents of blunt cervical trauma and a single postoperative case of pedal edema; all were considered mild and resolved spontaneously. Postprocedure surveys indicated that 95% of reporting physicians were “satisfied” or “highly satisfied” with device performance. >Conclusions: Hysteroscopic morcellation of intrauterine pathology was accomplished safely with a high degree of physician satisfaction in 278 patients treated in diverse healthcare settings that are reflective of general community practice in the United States. (J GYNECOL SURG 32:318)
机译:>背景:宫腔镜粉碎术可在直接可视化下去除子宫病理,并连续实时去除组织碎片。 >目的:本研究的目的是探讨宫腔镜粉碎术在包括手术和办公室在内的各种设施中的可行性。 >设计:这是一项前瞻性的单臂多中心注册表开发(加拿大工作组II-3级)。 >材料和方法: 34位美国妇产科机构将受试者纳入了注册表。纳入标准为年龄在18-65岁之间,有宫腔镜子宫肌瘤切除术和/或息肉切除术适应症的女性,这些患者接受了MyoSure®宫腔镜组织切除系统(Hologic Inc.,马萨诸塞州,马萨诸塞州)治疗。记录宫腔内病变类型/大小和清除参数,不良事件(AE)和医生满意度等级。 >结果:从278名登记的受试者(平均年龄:43.9±9.0岁)中去除了559种病变(187个肌瘤; 372个息肉),并在非卧床手术中心进行了250例手术(89.9%)或医院门诊患者中的28个(10.1%)在妇科办公室中。大多数患者(n = 206,74.1%)接受了子宫异常出血的治疗,其中42例(15.1%)接受了不孕治疗。平均肌瘤直径为2.2±±1.2 cm。息肉平均直径为1.3±1.0±1.0cm。切除病理的总体平均百分比为95.4%(息肉99.3%,肌瘤86.8%)。五个AE包括四次钝性宫颈外伤事件和一例脚踏板浮肿的术后病例。所有患者均被视为轻度且自发消退。术后调查表明,有95%的报告医师对设备的性能“满意”或“高度满意”。 >结论:宫腔镜子宫内粉碎术在278名接受各种医疗保健治疗的患者中安全完成,医生满意程度很高,这反映了美国的一般社区实践。 (妇科医学杂志32:318)

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