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

Abstract

This randomised controlled trial (RCT) by Kroese et al. tackles an interesting, common gynaecological condition of significant clinical importance. It is original work as the previous RCTs (Ander-sen et al. Acta Obstet Gynecol Scand 1992;71:59-62; Gennis et al. Am J Emerg Med 2005;23:414-15) were small, and not as well designed. When appropriately designed, conducted and reported, RCTs represent the reference standard in evaluating healthcare interventions. This RCT demonstrated that in women with an abscess or cyst of the Bartholin gland, treatment with Word catheter or marsu-pialisation resulted in comparable recurrence rates. Median time from ran-domisation to treatment was 3 hours shorter for Word catheter than for mar-supialisation. Maximal and average pain experienced during treatment were both higher in the Word catheter group compared with marsupialisation. However, pain scores after treatment were comparable , although those women undergoing marsupialisation required more analgesia during the first postoperative day. There are obviously other confounding factors affecting the recurrence rate, such as diabetes. How did the authors address that issue and was there any trend difference in the diabetic group? In other words, in a woman with diabetes how can the authors reliably make inferences that the recurrence is method/technique-related and not attributed to her dia-betes? This RCT is well designed, conducted and adequately implemented the Consolidated Standards of Reporting Trials recommendations (CONSORT) (Schulz, et al. BMJ 2010;340:c332). One of these recommendations is that the trial's results be discussed in light of the totality of the available evidence. There is explicit reference in the discussion to the results of the systematically conducted , published review of previously reported studies, explaining why the current study was justified. I agree with the authors' statements that the strengths of this RCT are the following. 1. The multicentre design within 19 hospitals reflects daily practice, and allows generalisation of the results. 2. A robust follow up, exclusion criteria and follow-up strategy have been conducted. However, I am not sure why women under 18 years were excluded, not under 16 years for instance. I wonder whether the latter would have expedited the recruitment and shortened the duration of the study (2010-14)? 3. The sample size calculation meant that the RCT is adequately powered to result in meaningful conclusions. 4. Statistical analysis was performed according to the intention-to-treat principle. This RCT also adapts the proposal by Docherty et al. (BMJ 1999; 318:1224-5) stating the main results, the strengths and limitations, interpretation/ comparison with the previous reviews/ RCTs and literature, but could have elaborated further on implication on clinical practice. The authors stated that 'In our opinion, our data therefore favour treatment of a Bartholin cyst or abscess with a Word catheter since this is the fastest procedure, relieving pain sooner after diagnosis,...

Evaluation of treatments for Bartholin’s cyst or abscess: a systematic review

“…Four trials, reporting data from 560 women, compared marsupialisation with a variety of other treatments (see Supplementary material, Appendix S2). 11,15,16,18 Comparing marsupialisation with incision, drainage and insertion of a Word catheter, the evidence was consistent with notable effects in either direction (RR 0.76; 95% CI 0.41-1.40) ( Figure 2). When comparing marsupialisation with incision, drainage and insertion of a Word catheter, the evidence suggests that if the risk of recurrence is 23% in the incision, drainage and insertion of a Word catheter group, then the risk in the marsupialisation group would be 9.5-32.4%.…”

“…Given the evidence at hand, the authors in line with the conclusions made by Kroese et al, 15 recommend incision, drainage and insertion of a Word catheter to be considered as the first-line treatment for a symptomatic cyst or abscess of the Bartholin's gland. Although current evidence does not indicate differences in the rates of recurrence of a symptomatic cyst or abscess of the Bartholin's gland when compared with marsupialisation, the insertion of a Word catheter offers other advantages, including the ability to undertake the procedure within an office setting, the avoidance of general anaesthesia, and reductions in resource utilisation such as hospital beds and usage of operating theatre time.…”

“…Included randomised trials evaluated eight different interventions including marsupialisation, incision, drainage and insertion of a Word catheter, and incision, drainage and silver nitrate insertion (Table ). The included randomised trials were relatively small, ranging from 22 to 212 women (median 44 women) .…”

“…Eight randomised trials, reporting data from 699 women, met our inclusion criteria ( Figure 1). [11][12][13][14][15][16][17][18] Included randomised trials evaluated eight different interventions including marsupialisation, 11,12,15,16,18 incision, drainage and insertion of a Word catheter, 13,15 and incision, drainage and silver nitrate insertion 14,17,18 ( Table 1). The included randomised trials were relatively small, ranging from 22 to 212 women (median 44 women).…”

“…The swelling had to be in the Bartholin outflow tract, as confirmed by a gynaecologist.' 15 The authors' judgements regarding the methodological quality of the included studies are detailed in Table 1.…”