Department of Obstetrics and Gynaecology, Medical Spectrum Twente, Enschede, the Netherlands.
Department of Obstetrics and Gynaecology, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.
BJOG. 2017 Jan;124(2):243-249. doi: 10.1111/1471-0528.14281. Epub 2016 Sep 19.
To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using a Word catheter or marsupialisation.
Multicentre, open-label, randomised controlled trial.
Eighteen hospitals in the Netherlands and one hospital in England.
Women with a symptomatic cyst or abscess of the Bartholin gland.
Women were randomised to treatment with Word catheter or marsupialisation.
The primary outcome was recurrence of the cyst or abscess within 1 year of treatment. The secondary outcomes included pain during and after treatment (measured on a 10-point scale), use of analgesics, and time from diagnosis to treatment. Analysis was by intention-to-treat. To assess whether marsupialisation would reduce the recurrence rate by 5% (from 20 to 15%) we needed to include 160 women (alpha error 0.05, beta error 0.2).
One hundred and sixty-one women were randomly allocated to treatment by Word catheter (n = 82) or marsupialisation (n = 79) between August 2010 and May 2014. Baseline characteristics were comparable. Recurrence occurred in 10 women (12%) allocated to Word catheter versus eight women (10%) allocated to marsupialisation: relative risk (RR) 1.1, 95% confidence interval (CI) 0.64-1.91; P = 0.70. Pain scores after treatment were also comparable. In the first 24 hours after treatment, 33% used analgesics in the Word catheter group versus 74% in the marsupialisation group (P < 0.001). Time from diagnosis to treatment was 1 hour for placement of Word catheter versus 4 hours for marsupialisation (P = 0.001).
In women with an abscess or cyst of the Bartholin gland, treatment with Word catheter and marsupialisation results in comparable recurrence rates.
Comparable recurrence rates for treatment of Bartholinic abscess/cyst with Word catheter and marsupialisation.
比较使用沃氏导尿管或袋形缝合术治疗巴氏腺囊肿或脓肿后的复发情况。
多中心、开放标签、随机对照试验。
荷兰的 18 家医院和英国的 1 家医院。
患有巴氏腺囊肿或脓肿的有症状的女性。
将女性随机分配接受沃氏导尿管或袋形缝合术治疗。
主要结局是治疗后 1 年内囊肿或脓肿的复发情况。次要结局包括治疗期间和治疗后的疼痛（用 10 分制衡量）、镇痛药的使用情况以及从诊断到治疗的时间。分析采用意向治疗。为了评估袋形缝合术是否能将复发率降低 5%（从 20%降至 15%），我们需要纳入 160 名女性（α错误 0.05，β错误 0.2）。
2010 年 8 月至 2014 年 5 月期间，161 名女性被随机分配接受沃氏导尿管（n=82）或袋形缝合术（n=79）治疗。基线特征具有可比性。10 名（12%）接受沃氏导尿管治疗的女性和 8 名（10%）接受袋形缝合术治疗的女性出现复发：相对风险（RR）1.1，95%置信区间（CI）0.64-1.91；P=0.70。治疗后疼痛评分也相当。治疗后 24 小时内，沃氏导尿管组有 33%的人使用了镇痛药，而袋形缝合术组有 74%的人使用了镇痛药（P<0.001）。从诊断到治疗的时间，沃氏导尿管为 1 小时，袋形缝合术为 4 小时（P=0.001）。
在患有巴氏腺脓肿或囊肿的女性中，使用沃氏导尿管和袋形缝合术治疗的复发率相当。
沃氏导尿管和袋形缝合术治疗巴氏腺脓肿/囊肿的复发率相当。
