Department of Obstetrics and Gynaecology, Imelda Hospital, Bonheiden, Belgium.
Department of Anaesthesiology, Imelda Hospital, Bonheiden, Belgium.
BJOG. 2019 Jan;126(1):105-113. doi: 10.1111/1471-0528.15504.
To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) as a day-care procedure.
Parallel group, 1:1 randomised single-centre single-blinded trial, designed as a non-inferiority study with a margin of 15%.
Belgian teaching hospital.
Women aged 18-70 years scheduled to undergo hysterectomy for benign indications.
Randomisation to TLH (control group) or vNOTES (experimental group). Stratification according to uterine volume. Blinding of participants and outcome assessors.
The primary outcome was hysterectomy by the allocated technique. We measured the proportion of women leaving within 12 hours after hysterectomy and the length of hospital stay as secondary outcomes.
We randomly assigned 70 women to vNOTES (n = 35) or TLH (n = 35). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the TLH group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 7.5%, which is below the predefined non-inferiority margin. More women left the hospital within 12 hours after surgery after vNOTES: 77 versus 43%, difference 34% (95% CI 13-56%), P = 0.007. The hospital stay was shorter after vNOTES: 0.8 versus 1.3 days, mean difference -0.5 days, (95% CI -0.98 to -0.02), P = 0.004.
vNOTES is non-inferior to TLH for successfully performing hysterectomy without conversion. Compared with TLH, vNOTES may allow more women to be treated in a day-care setting.
RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery.
比较经阴道自然腔道内镜手术（vNOTES）与全腹腔镜子宫切除术（TLH）作为日间手术的优劣。
平行组、1:1 随机分组、单中心、单盲试验，设计为非劣效性研究，边界为 15%。
比利时教学医院。
年龄 18-70 岁，因良性疾病行子宫切除术的女性。
TLH（对照组）或 vNOTES（实验组）随机分组。根据子宫体积分层。参与者和结果评估者设盲。
主要结局为按分配技术行子宫切除术。我们测量了 12 小时内出院的女性比例和住院时间作为次要结局。
我们将 70 名女性随机分配至 vNOTES（n=35）或 TLH（n=35）。两组均达到了主要终点：均未中转开腹。我们对主要结局进行了敏感性分析，假设 vNOTES 组有 1 例中转开腹，TLH 组无中转开腹：单侧 95%置信区间上限估计转换率的差异为 7.5%，低于预设的非劣效性边界。更多的女性在 vNOTES 手术后 12 小时内出院：77%比 43%，差异 34%（95%CI 13-56%），P=0.007。vNOTES 术后住院时间更短：0.8 天比 1.3 天，平均差 -0.5 天（95%CI -0.98 至 -0.02），P=0.004。
vNOTES 在不中转开腹的情况下成功进行子宫切除术，与 TLH 相比非劣效。与 TLH 相比，vNOTES 可能使更多的女性能够在日间手术中得到治疗。
RCT：vNOTES 在不中转开腹的情况下成功进行子宫切除术与腹腔镜手术相当，但可使更多的手术在日间完成。
