Protocol for a modified vaginal pipe for total laparoscopic hysterectomies: Experimental research.
Protocol for a modified vaginal pipe for total laparoscopic hysterectomies: Experimental research.
复制标题
用于全腹腔镜子宫切除术的改良阴道管方案：实验研究。
DOI：
10.1016/j.isjp.2020.02.003
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发表时间：
2020
影响因子：
0.9
通讯作者：
Kitawaki J.
中科院分区：
文献类型：
--
作者：
Ito F;Kokabu T;Matsushima H;Koshiba A;Mori T;Kusuki I;Kitawaki J.
背景：Vagi-Pipe®是一种用于腹腔镜全子宫切除术的有用装置。传统的阴道导管在阴道切开术中无法抓住子宫以恢复切除的子宫。然而，改良的c型阴道管®模型具有无需移除子宫操纵器即可插入阴道的形状。在本研究中，我们将前瞻性地探讨c型阴道管®在腹腔镜全子宫切除术中的安全性和有效性。材料与方法：共纳入25例年龄在20 ~ 60岁的女性子宫肌瘤或子宫腺肌症患者。有研究者认为不适合本研究的并发症的患者将被排除。在进行全腹腔镜子宫切除术时，将使用c型阴道导管而不是传统的阴道导管。主要终点是安全性，次要终点是手术时间、出血量和并发症的存在。伦理和传播：该方案得到了机构审查委员会的批准。根据《赫尔辛基宣言》，在注册前将获得所有患者的书面知情同意。研究结果将通过同行评议期刊的出版物进行传播。
Background:The Vagi-Pipe® is a useful device for performing a total laparoscopic hysterectomy. The conventional model of the Vagi-Pipe® is unable to grasp the uterus during colpotomy for recovery of the resected uterus. However, the modified C-Type Vagi-Pipe® model has a shape that allows insertion into the vagina without removing the uterus manipulator. In this study, we will prospectively investigate the safety and efficacy of the C-Type Vagi-Pipe® in total laparoscopic hysterectomies.Materials and methods:In total, 25 female subjects aged between 20 and 60 years with uterine fibroids or adenomyosis will be included. Patients with complications regarded as unsuitable for this study by the investigators will be excluded. The C-Type Vagi-Pipe® will be used rather than the conventional Vagi-Pipe® when performing a total laparoscopic hysterectomy. The primary endpoint will be safety and the secondary endpoints will be operation time, bleeding volume, and presence of complications.Ethics and dissemination:The protocol was approved by the institutional review boards. Written informed consent will be obtained from all patients before registration in accordance with the Declaration of Helsinki. Results of the study will be disseminated via publications in peer-reviewed journals.