J A Kroese1, M van der Velde1, L P Morssink2, M H Zafarmand3,4, P Geomini5, Pjm van Kesteren6, C M Radder7, L F van der Voet8, Jpwr Roovers3, Gcm Graziosi9, W M van Baal10, J van Bavel11, R Catshoek12, E R Klinkert13, Jaf Huirne14, T J Clark15, Bwj Mol16, N Reesink-Peters1. 1. Department of Obstetrics and Gynaecology, Medical Spectrum Twente, Enschede, the Netherlands. 2. Department of Obstetrics and Gynaecology, Medical Centre Leeuwarden, Leeuwarden, the Netherlands. 3. Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, the Netherlands. 4. Department of Public Health, Academic Medical Centre, Amsterdam, the Netherlands. 5. Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, the Netherlands. 6. Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands. 7. Department of Obstetrics and Gynaecology, Saint Lucas Andreas Hospital, Amsterdam, the Netherlands. 8. Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, the Netherlands. 9. Department of Obstetrics and Gynaecology, Antonius Hospital, Nieuwegein, the Netherlands. 10. Department of Obstetrics and Gynaecology, Flevoziekenhuis, Almere, the Netherlands. 11. Department of Obstetrics and Gynaecology, Amphia Hospital, Breda, the Netherlands. 12. Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, the Netherlands. 13. Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, the Netherlands. 14. Department of Obstetrics and Gynaecology, Vrije University Medical Centre, Amsterdam, the Netherlands. 15. Department of Obstetrics and Gynaecology, Birmingham Women's Hospital, Birmingham, UK. 16. The Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, Australia.
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.
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.