1. Word catheter and marsupialisation in women with a cyst or abscess of the Bartholin gland (WoMan-trial): a randomised clinical trial.
- Author
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Kroese, JA, Velde, M, Morssink, LP, Zafarmand, MH, Geomini, P, Kesteren, PJM, Radder, CM, Voet, LF, Roovers, JPWR, Graziosi, GCM, Baal, WM, Bavel, J, Catshoek, R, Klinkert, ER, Huirne, JAF, Clark, TJ, Mol, BWJ, Reesink‐Peters, N, Kroese, J A, and van der Velde, M
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DISEASES in women , *BARTHOLIN'S gland , *ABSCESSES , *CYSTS (Pathology) , *DISEASES , *SURGERY , *CATHETERIZATION , *CATHETERS , *COMPARATIVE studies , *GYNECOLOGIC surgery , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *EVALUATION research , *RANDOMIZED controlled trials , *TREATMENT effectiveness , *EQUIPMENT & supplies - Abstract
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. [ABSTRACT FROM AUTHOR]- Published
- 2017
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