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阴道子宫切除术与经阴道自然腔道内镜辅助子宫切除术的随机对照试验

Vaginal Hysterectomy Versus Vaginal Assisted Natural Orifice Transluminal Endoscopic Surgery Hysterectomy; Results of a Randomised Controlled Trial.
PubMed 文献 · BJOG · 2026-05-15

该单盲多中心随机对照试验在两家荷兰非学术教学医院比较了阴道子宫切除术(VH)与经阴道自然腔道内镜辅助子宫切除术(VANH)作为日间手术的效果。共113例良性指征患者按1:2随机分配(VH 42例,VANH 71例),VANH组日间手术成功率显著更高(87.3% vs 71.4%;OR 2.76,95%CI 1.04-7.25;P=0.04),且手术时间更短、出血更少、机会性输卵管切除率更高,并发症及恢复指标无显著差异。

要点

  • VANH组日间手术成功率为87.3%,显著高于VH组的71.4%(OR 2.76,95%CI 1.04-7.25;P=0.04)。
  • VANH组手术时间中位55分钟,短于VH组的65分钟(P=0.005),出血量中位50mL少于150mL(P<0.001)。
  • VANH组机会性输卵管切除率100%,高于VH组的77.4%(P=0.008),并发症与恢复指标无显著差异。

核心结论

  • VANH是VH安全有效的替代方案,日间手术可能性更高、手术时间更短、出血更少且机会性输卵管切除更常见,不增加并发症或疼痛、恢复及生活质量差异。

研究设计与样本

  • 单盲、多中心随机对照试验,在两家荷兰非学术教学医院开展,纳入年龄≥18岁因良性指征行子宫切除术的女性,按1:2随机分配至VH或VANH组,按意向性分析。

主要发现

  • 共113例纳入分析(VH组42例,VANH组71例)。
  • VANH组日间手术成功率87.3%,VH组71.4%(OR 2.76,95%CI 1.04-7.25;P=0.04)。
  • VANH组手术时间中位55分钟 vs VH组65分钟(P=0.005),出血量中位50mL vs 150mL(P<0.001)。
  • VANH组机会性输卵管切除率100% vs VH组77.4%(P=0.008)。
  • VANH组术后第一小时NRS疼痛评分显著更低(3 vs 1,P<0.001);术后并发症(VH 9.5% vs VANH 15.5%;P=0.34)、再入院(VH 4.8% vs VANH 8.5%;P=0.47)、镇痛药使用、恢复及生活质量无统计学显著差异。

临床怎么用

  • 对于因良性指征需行子宫切除术的女性,VANH可提高日间手术完成率并缩短手术时间、减少出血,且不增加并发症风险。
  • VANH更有利于实施机会性输卵管切除,但需结合术者技术条件与患者具体情况个体化选择。

局限性

  • 样本量较小(共113例),可能影响次要结局的统计效能。
  • 研究在两家荷兰非学术教学医院开展,外推性需谨慎。
  • 单盲设计可能对部分主观结局评估产生影响。

以上解读依据论文摘要(全文未开放获取或许可不允许翻译转载)。

原文

OBJECTIVE: To compare Vaginal Hysterectomy (VH) with Vaginal Assisted Natural Orifice Transluminal Endoscopic Surgery (NOTES) hysterectomy (VANH) as a day-care procedure. DESIGN: Single-blind, multicentre randomised controlled trial. SETTING: Two Dutch non-academic teaching hospitals. POPULATION: Women aged ≥ 18 years undergoing hysterectomy for benign indications. METHODS: Women were randomised 1:2 (VH or VANH). Primary outcome was SDD. Secondary outcomes included operative time, rate of elective salpingectomies, intraoperative blood loss, complications (Clavien-Dindo), pain scores (NRS) and analgesic use, post-operative recovery (RI-10), and quality of life (EQ-5D-5L). Analyses were performed on an intention-to-treat basis. RESULTS: A total of 113 patients were included in the analyses (n = 42 VH, and n = 71 VANH). SDD occurred significantly more frequently in the VANH group (87.3%) than VH group (71.4%; OR 2.76, 95% CI 1.04-7.25; p = 0.04). VANH was associated with a significantly shorter operative time (median 55 min versus 65 min; p = 0.005), less blood loss (median 50 mL vs. 150 mL; p < 0.001) and more often elective opportunistic salpingectomy compared to VH (100% vs. 77.4%; p = 0.008). NRS were significantly lower in the VANH group the first hour post-operative (3 vs. 1, p < 0.001). Post-operative complications (VH 9.5% vs. VANH 15.5%; p = 0.34), readmission (VH 4.8% vs. VANH 8.5%; p = 0.47), analgesic use, recovery, and quality of life were not statistically significant. CONCLUSIONS: VANH is a safe and effective alternative to VH, offering a higher likelihood of SDD, shorter operative time, reduced blood loss, and more often an elective salpingectomy, without increased complications or differences in pain, recovery, or quality of life.

来源:BJOG,查看原文。版权归原作者所有。

引用

  1. Bekkers IPW, Wintraecken FRM, Smeets NAC, et al. Vaginal Hysterectomy Versus Vaginal Assisted Natural Orifice Transluminal Endoscopic Surgery Hysterectomy; Results of a Randomised Controlled Trial. BJOG. 2026. PMID: 42137913. doi:10.1111/1471-0528.70260

供执业医师工作参考,不替代临床判断;数值与分级以指南原文为准。