Word catheter and marsupialisation in women with a cyst or abscess of the Bartholin gland (WoMan‐trial): a randomised clinical trial

摘要

Objective To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using a Word catheter or marsupialisation. Design Multicentre, open‐label, randomised controlled trial. Setting Eighteen hospitals in the Netherlands and one hospital in England. Population Women with a symptomatic cyst or abscess of the Bartholin gland. Methods Women were randomised to treatment with Word catheter or marsupialisation. Main outcome measures 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). Results 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). Conclusions In women with an abscess or cyst of the Bartholin gland, treatment with Word catheter and marsupialisation results in comparable recurrence rates. Tweetable abstract Comparable recurrence rates for treatment of Bartholinic abscess/cyst with Word catheter and marsupialisation.