Overdijk Lucilla E, Rademaker Bart M P, van Kesteren Paul J M, de Haan Peter, Riezebos Robert K, Haude Oscar C H
OLVG Hospital, Oosterparkstraat 9, 1091 AC, Amsterdam, Netherlands.
University of Amsterdam/AMC Hospital, Meibergdreef 9, 1105 AZ, Amsterdam, Netherlands.
Trials. 2018 Feb 14;19(1):107. doi: 10.1186/s13063-018-2442-9.
Transcervical resection of myoma or endometrium is a safe, hysteroscopic, minimally invasive procedure. However, intravasation of distension fluid is a common phenomenon during these procedures. In a previous study we observed venous gas emboli in almost every patient. The severity of hysteroscopic-derived embolization has been shown to be correlated to the amount of intravasation. In addition, paradoxical gas embolism, which is potentially dangerous, was observed in several patients. Studies have shown a reduction of intravasation by using intracervically administered vasopressin during hysteroscopy. We think that its analog, terlipressin, should have the same effect. In our previous research we observed more gaseous emboli as intravasation increased. Whether or not the insertion of intracervically administered terlipressin leads to a lower incidence and severity of gas embolism is unknown. We hypothesize that intracervically administered terlipressin leads to a reduction of intravasation with a lower incidence and severity of gas embolism. Terlipressin may be of benefit during hysteroscopic surgery.
METHODS/DESIGN: Forty-eight patients (ASA 1 or 2) scheduled for transcervical resection of large, types 1-2 myoma or extensive endometrium resection will be included. In a double-blind fashion patients will be randomized 1:1 according to surgical treatment using either intracervically administered terlipressin or placebo. Transesophageal echocardiography will be used to observe and record embolic events. A pre- and post-procedure venous blood sample will be taken to calculate intravasation based on hemodilution. Our primary endpoint will be how terlipressin influences the severity of embolic events. Secondary endpoints include the effect of terlipressin on the amount of intravasation and on hemodynamic parameters.
If terlipressin does indeed reduce the number of gaseous emboli and intravasation occurring during hysteroscopic surgery, it would be a simple method to minimize potential adverse events. It also allows for prolonged operating time before the threshold of intravasation is reached, thereby reducing the need for a second operation.
Nederlands Trial Register (Dutch Trial Register), ID: NTR5577 . Registered retrospectively on 18 December 2015.
经宫颈肌瘤切除术或子宫内膜切除术是一种安全的宫腔镜微创手术。然而，在这些手术过程中，膨胀液血管内灌注是一种常见现象。在之前的一项研究中，我们观察到几乎每位患者都出现了静脉气体栓塞。宫腔镜所致栓塞的严重程度已被证明与血管内灌注量相关。此外，在几名患者中观察到了具有潜在危险的反常气体栓塞。研究表明，宫腔镜检查期间通过宫颈内注射血管加压素可减少血管内灌注。我们认为其类似物特利加压素应具有相同效果。在我们之前的研究中，我们观察到随着血管内灌注增加，气体栓塞增多。宫颈内注射特利加压素是否会降低气体栓塞的发生率和严重程度尚不清楚。我们假设宫颈内注射特利加压素可减少血管内灌注，降低气体栓塞的发生率和严重程度。特利加压素在宫腔镜手术中可能有益。
方法/设计：将纳入48例计划行经宫颈1 - 2型大肌瘤切除术或广泛子宫内膜切除术的患者（美国麻醉医师协会分级1或2级）。患者将以双盲方式根据手术治疗随机分为1:1两组，分别接受宫颈内注射特利加压素或安慰剂。将使用经食管超声心动图观察和记录栓塞事件。术前和术后采集静脉血样，根据血液稀释情况计算血管内灌注量。我们的主要终点是特利加压素如何影响栓塞事件的严重程度。次要终点包括特利加压素对血管内灌注量和血流动力学参数的影响。
如果特利加压素确实能减少宫腔镜手术期间发生的气体栓塞数量和血管内灌注，那将是一种使潜在不良事件最小化的简单方法。它还能在达到血管内灌注阈值之前延长手术时间，从而减少二次手术的必要性。
荷兰试验注册库（荷兰试验注册），编号：NTR5577。于2015年12月18日追溯注册。
