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Creation of a novel inflatable vaginal stent for McIndoe vaginoplasty
Fertility and Sterility ( IF 6.6 ) Pub Date : 2020-12-01 , DOI: 10.1016/j.fertnstert.2020.09.030
Phillip A Romanski 1 , Pietro Bortoletto 1 , Samantha M Pfeifer 1
Affiliation  

OBJECTIVE To describe how to create an inflatable vaginal stent for use in McIndoe vaginoplasty that can be constructed using standard operating room supplies. DESIGN Step-by-step video instructions that demonstrate how to construct and use an inflatable vaginal stent. (This video article was exempt from institutional review board approval.) SETTING: Academic hospital. PATIENT(S) A woman presenting with vaginal agenesis requiring a McIndoe vaginoplasty for the creation of a neovagina. INTERVENTION(S) A novel inflatable vaginal stent compliant with operating room procedures that is radio-opaque, functional, and can be used for patients with or without a functional uterus. The device is modeled after the effective inflatable vaginal stent that was previously commercially available but is no longer produced. Although a vaginal stent may be created in the operating room by placing surgical sponges inside a sterilized condom, many operating rooms have restrictions on equipment that can be brought into the operating room and special criteria for how to sterilize this equipment, and there are also restrictions against leaving non-radio-opaque objects "inside" the patient. The novel inflatable vaginal stent we have developed has multiple advantages compared with a rigid dilator: it is deflatable, so it does not cause trauma or interrupt the delicate tissue graft during insertion, removal, or repositioning; it is firm enough to conform and circumferentially press the tissue graft against the dissected vaginal space but is soft enough to decrease the risk of pressure necrosis or damage to the urethra; and it has a drainage port to prevent the buildup of a fluid pocket that could interfere with graft adherence. Our stent incorporates all these unique properties and can be easily constructed using sterile operating room supplies. The construction of this device requires a silicone Foley catheter, sterile foam sponges from a vaginal prep kit, a sterile radio-opaque sponge, a sterile vaginal ultrasound probe cover, a long Kelly, a 60-cc catheter tip syringe, a ruler, scissors, 0-vicryl suture, and sterile gloves. MAIN OUTCOME MEASURE(S) Effectiveness of a self-made inflatable vaginal stent using standard operating room supplies that meets operating room protocol standards. RESULT(S) A standard dose of prophylactic antibiotics should be administered preoperatively to prevent surgical site infection. After placement of the tissue graft in the dissected neovagina cavity, the vaginal stent is placed and slowly inflated to circumferentially apply the tissue graft against the dissected vaginal space. The stent remains in place for 7 days and then should be removed in the operating room to allow for an examination under anesthesia, which provides the ideal setting to best evaluate the initial graft adherence. After careful inspection of the neovagina and tissue graft, a standard silicone vaginal mold is placed to maintain vaginal patency and prevent stricture of the tissue graft. The silicone mold should remain in place continuously until complete graft adherence occurs (approximately 4 to 6 weeks), and then it can be worn nightly until the patient is regularly sexually active. If at any point the patient discontinues nightly use of the silicone mold before regular sexual activity, vaginal stricture and a decrease in vaginal caliber will occur. CONCLUSION(S) Our novel inflatable vaginal stent is useful to surgeons performing a McIndoe vaginoplasty for vaginal agenesis with or without a uterus. It is compliant with operating room protocols and restrictions, as it is constructed from operating room supplies and is radio-opaque. Moreover, it is adjustable in size and effective in applying circumferential pressure for graft adherence. When used for segmental vaginal agenesis, the Foley catheter may be advanced through the cervix, then the balloon can be inflated, to stabilize the position of the stent during the first week postoperatively. The main limitation of this device is that it must be constructed by the surgeon, but the advantage of self-constructing the stent is that the size and shape can be tailored to conform to each individual patient. We prefer this inflatable vaginal stent to a rigid vaginal dilator in the first week of tissue healing to allow for easy insertion and removal of the stent without disrupting the tissue graft, to help prevent tissue necrosis, and to provide a fluid drainage port during graft adherence. We recommend this device as an ideal option for surgeons to consider when performing a McIndoe vaginoplasty.

中文翻译:

用于 McIndoe 阴道成形术的新型充气阴道支架的研制

目的 描述如何制造可用于 McIndoe 阴道成形术的可充气阴道支架,该支架可使用标准手术室用品制造。设计 演示如何构建和使用充气阴道支架的分步视频说明。(此视频文章免于机构审查委员会的批准。) 设置:学术医院。患者 (S) 一名出现阴道发育不全的女性,需要进行 McIndoe 阴道成形术以创建新阴道。INTERVENTION(S) 一种新型可充气阴道支架,符合手术室程序,不透射线,具有功能性,可用于有或没有功能性子宫的患者。该装置以有效的可充气阴道支架为模型,该支架以前市售但不再生产。尽管可以在手术室通过将手术海绵放入消毒过的避孕套内来制造阴道支架,但许多手术室对可以带入手术室的设备以及如何对该设备进行消毒的特殊标准都有限制,并且也有限制反对将非辐射不透明物体留在患者“体内”。与刚性扩张器相比,我们开发的新型充气阴道支架具有多个优点:可放气,因此在插入、移除或重新定位过程中不会造成创伤或中断脆弱的组织移植物;它足够坚固以贴合并沿圆周将组织移植物压在解剖的阴道空间上,但足够柔软以降低压力性坏死或尿道损伤的风险;并且它有一个排水口,以防止积聚可能干扰移植物粘附的液袋。我们的支架结合了所有这些独特的特性,可以使用无菌手术室用品轻松构建。该设备的构造需要硅胶 Foley 导管、阴道准备套件中的无菌泡沫海绵、无菌不透射线海绵、无菌阴道超声探头盖、长凯利、60 cc 导管尖端注射器、尺子、剪刀, 0-vicryl 缝合线和无菌手套。主要结果测量使用符合手术室协议标准的标准手术室用品自制充气阴道支架的有效性。结果 术前应给予标准剂量的预防性抗生素以防止手术部位感染。将组织移植物放置在解剖的新阴道腔中后,放置阴道支架并缓慢膨胀以将组织移植物沿圆周施加到解剖的阴道空间。支架保留在原位 7 天,然后应在手术室中取出,以便在麻醉下进行检查,这为最好地评估初始移植物粘附性提供了理想的环境。在仔细检查新阴道和组织移植物后,放置标准硅胶阴道模具以保持阴道通畅并防止组织移植物狭窄。硅胶模具应持续保持原位,直至移植物完全粘连(大约 4 至 6 周),然后可以每晚佩戴,直到患者有规律地进行性活动。如果在任何时候患者在有规律的性活动之前停止每晚使用硅胶模具,阴道狭窄和阴道口径会下降。结论 (S) 我们的新型充气阴道支架对于进行 McIndoe 阴道成形术治疗有或没有子宫的阴道发育不全的外科医生很有用。它符合手术室协议和限制,因为它由手术室用品构成并且不透射线。此外,它的尺寸可调,有效地施加圆周压力以实现移植物粘附。当用于节段性阴道发育不全时,可将 Foley 导管通过宫颈推进,然后球囊可以膨胀,以在术后第一周稳定支架的位置。该设备的主要限制是它必须由外科医生构建,但是自建支架的优点是可以定制尺寸和形状以适应每个患者。在组织愈合的第一周,我们更喜欢这种充气式阴道支架,而不是刚性阴道扩张器,以便在不破坏组织移植物的情况下轻松插入和移除支架,帮助防止组织坏死,并在移植物粘附期间提供液体引流口. 我们推荐该设备作为外科医生在进行 McIndoe 阴道成形术时考虑的理想选择。有助于防止组织坏死,并在移植物粘附期间提供液体引流口。我们推荐该设备作为外科医生在进行 McIndoe 阴道成形术时考虑的理想选择。有助于防止组织坏死,并在移植物粘附期间提供液体引流口。我们推荐该设备作为外科医生在进行 McIndoe 阴道成形术时考虑的理想选择。
更新日期:2020-12-01
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