Department of Obstetrics and Gynaecology, Amsterdam UMC, VU Universiteit Amsterdam, De Boelelaan 1117 Amsterdam, the Netherlands.
Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, 7500 KA, the Netherlands.
Eur J Obstet Gynecol Reprod Biol. 2019 May;236:127-132. doi: 10.1016/j.ejogrb.2019.02.035. Epub 2019 Mar 6.
To assess the capacity of transvaginal hydrolaparoscopy (THL) versus hysterosalpingography (HSG) as a primary tool to diagnose tubal pathology.
We performed a multicenter RCT (NTR3462) in 4 teaching hospitals in the Netherlands, comparing THL and HSG as first line tubal test in subfertile women. The primary outcome of the trial was cumulative live birth rate at 24 months. Here, we present the secondary outcomes, the diagnostic findings of both THL and HSG as well as performance defined as failures, complications and pain- and acceptability scores.
Between May 2013 and October 2016, we allocated 149 women to THL and 151 to HSG, of which 17 women in the THL group (11.4%) and 12 in the HSG group (7.9%) conceived naturally before the scheduled procedure, while 13 HSGs and 5 THLs were not performed for other reasons (withdrawal of informed consent, not willing to undergo tubal testing and protocol violations). A total of 119 THLs and 134 HSGs were carried out. Failures were seen more in the THL group (n = 8, 5.6%) than in the HSG group (n = 1, 0.7%) (p = 0.014). Complications did not differ significantly between the groups (THL n = 4; 2.8% vs HSG n = 1; 0.7%) (p = 0.20). Bilateral tubal occlusion was detected in one versus three women (0.9% versus 2.2%) of the THL group and HSG group, while unilateral tubal occlusion was detected in seven (6.2%) versus eight (5.9%) women, respectively. Normal findings were seen in 96 (79.3%) women randomised to THL and in 119 (87.5%) in women randomised for HSG (RR 0.91 95%CI 0.81-1.01, p = 0.08). The pain score was significantly less for THL (VAS 4.7 (SD: 2.5)) than for HSG (VAS 5.4 (SD:2.5)) (p 0.038). The acceptability rate of THL and was high and comparable.
THL and HSG have a comparable capacity in diagnosing tubal pathology with comparable performance in safety, pain and acceptability.
评估经阴道注水腹腔镜（THL）与子宫输卵管造影（HSG）作为诊断输卵管病变的主要工具的能力。
我们在荷兰的 4 家教学医院进行了一项多中心 RCT（NTR3462），比较 THL 和 HSG 作为不孕妇女的一线输卵管检查。试验的主要结局是 24 个月时的累积活产率。在这里，我们介绍次要结局，即 THL 和 HSG 的诊断结果以及定义为失败、并发症以及疼痛和可接受性评分的表现。
2013 年 5 月至 2016 年 10 月，我们将 149 名女性分配到 THL 组和 151 名女性分配到 HSG 组，其中 THL 组有 17 名女性（11.4%）和 HSG 组有 12 名女性（7.9%）在预定手术前自然受孕，而 13 例 HSG 和 5 例 THL 因其他原因未进行（撤回知情同意、不愿进行输卵管检查和违反方案）。共进行了 119 例 THL 和 134 例 HSG。THL 组的失败率（n=8，5.6%）明显高于 HSG 组（n=1，0.7%）（p=0.014）。两组的并发症无显著差异（THL n=4；2.8%vs HSG n=1；0.7%）（p=0.20）。THL 组有 1 例（0.9%）和 HSG 组有 3 例（2.2%）检测到双侧输卵管阻塞，而单侧输卵管阻塞在 THL 组有 7 例（6.2%）和 HSG 组有 8 例（5.9%）。THL 组有 96 名（79.3%）女性和 HSG 组有 119 名（87.5%）女性的检查结果正常（RR 0.91 95%CI 0.81-1.01，p=0.08）。THL 的疼痛评分明显低于 HSG（VAS 4.7（SD：2.5））（p<0.038）。THL 和 HSG 的接受度均很高且相当。
THL 和 HSG 在诊断输卵管病变方面具有相当的能力，在安全性、疼痛和可接受性方面表现相当。
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