ObjectiveTo compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect.DesignMulticentre randomised controlled trial.SettingEleven hospitals collaborating in a consortium for women's health research in the Netherlands.PopulationWomen reporting postmenstrual spotting after a caesarean section who had a niche with a residual myometrium of ≥3 mm, measured during sonohysterography.MethodsWomen were randomly allocated to hysteroscopic niche resection or expectant management for 6 months.Main outcome measuresThe primary outcome was the number of days of postmenstrual spotting 6 months after randomisation. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, surgical parameters, quality of life, women's satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, except for niche measurements, also at 6 months after randomisation.ResultsWe randomised 52 women to hysteroscopic niche resection and 51 women to expectant management. The median number of days of postmenstrual spotting at baseline was 8 days in both groups. At 6 months after randomisation, the median number of days of postmenstrual spotting was 4 days (interquartile range, IQR 2–7 days) in the intervention group and 7 days (IQR 3–10 days) in the control group (P = 0.04); on a scale of 0–10, discomfort as a result of spotting had a median score of 2 (IQR 0–7) in the intervention group, compared with 7 (IQR 0–8) in the control group (P = 0.02).ConclusionsIn women with a niche with a residual myometrium of ≥3 mm, hysteroscopic niche resection reduced postmenstrual spotting and spotting‐related discomfort.Tweetable abstractA hysteroscopic niche resection is an effective treatment to reduce niche‐related spotting.
Objective To compare the effects of LigaSure versus the conventional bipolar technique on operating time and blood loss during laparoscopic hysterectomy.Design A randomised controlled trial.Setting Three teaching hospitals.Population Women undergoing a laparoscopic hysterectomy for benign indications.Methods 140 women undergoing a laparoscopic hysterectomy were randomised for LigaSure or conventional bipolar instruments.Main outcome measures Primary outcome was operating time from initial skin incision till detachment of the uterus. Secondary outcome measures were total operating time (from initial skin incision till final skin closure), time to dissect the adnexal ligaments, intra-operative blood loss and subjective evaluation by the surgeon of the instrument used.Results No differences in operating time (from initial skin incision till uterine detachment and initial skin incision till final skin closure) using LigaSure versus conventional bipolar instruments: 97.6 versus 91.8 minutes (P = 0.39, 95% CI -7.6 to 19.2), and 148.1 versus 142.1 minutes (P = 0.46, 95% CI -10.1 to 22.3), respectively. The mean blood loss using LigaSure versus conventional bipolar was 234.1 versus 273.1 ml (P = 0.46, 95% CI -39.1 to 52.7). Various subjective efficacy and instrument handling parameters were significantly different between the two instruments and between the different participating centres.Conclusions There were no significant differences in operating time and blood loss between the use of LigaSure and the use of conventional bipolar instruments during laparoscopic hysterectomy, even after correction for potential confounders. User satisfaction parameters were assessed as significantly different by surgeons of the participating centres.
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,...
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